Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAny medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.Xx_NEWLINE_xXPatients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this studyXx_NEWLINE_xXOther severe acute or chronic medical (including bone marrow suppressive diseases) or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, impede the ability of the patient to complete all protocol-specified activities, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this studyXx_NEWLINE_xXCo-morbid illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXNo known medical condition (e.g. a condition associated with uncontrolled diarrhea such as ulcerative colitis or acute diverticulitis) that, in the investigator’s opinion, would increase the risk associated with study participation or interfere with the interpretation of safety resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXSubjects with any other medical condition, including but not limited to malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the studyXx_NEWLINE_xXSubstance abuse, or medical, psychological or social conditions that may interfere with the patient's participation in the study or the evaluation of the study resultsXx_NEWLINE_xXSubjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the studyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXPatients with any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results, will not be eligibleXx_NEWLINE_xXAny other medical, psychiatric, or social condition, which in the opinion of the investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study resultsXx_NEWLINE_xXAny other medical or social condition deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the resultsXx_NEWLINE_xXPresence of any other condition that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry in the studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny severe concurrent disease or condition (includes active infections, cardiac arrhythmia, interstitial lung disease) that in the judgment of the investigator would make study participation inappropriate for the patient.Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this studyXx_NEWLINE_xXAny condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results.Xx_NEWLINE_xXAny condition that would prevent the patient’s participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study resultsXx_NEWLINE_xXAny medical condition or laboratory test abnormality that precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of resultsXx_NEWLINE_xXOther severe acute or chronic medical conditions including immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny known clinically significant concomitant medical condition, laboratory abnormality, or psychiatric illness that, in the investigator’s opinion, would prevent the subject from participating in the study, pose an unacceptable risk to the patient in this study, or interfere with the interpretation of safety resultsXx_NEWLINE_xXAny medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.Xx_NEWLINE_xXOther medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this studyXx_NEWLINE_xXSubstance abuse or medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.Xx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.Xx_NEWLINE_xXAny other condition that may interfere with compliance of the study protocolXx_NEWLINE_xXThe subject has a condition(s) that, in the opinion of the Investigator and/or Sponsor, would interfere with evaluation of the IMP or interpretation of the subject's safety or study results.Xx_NEWLINE_xXSubject has a condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the studyXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the subject to receive protocol therapy or interfere with the interpretation of study resultsXx_NEWLINE_xXSignificant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise the subject's safety or compliance or interfere with interpretation of study results.Xx_NEWLINE_xXAny other major illness that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation.Xx_NEWLINE_xXPresence of any condition that may increase the risks associated with study participation and interfere with the interpretation of study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXHistory of any medical or psychiatric condition or addictive disorder, or lab abnormality that in the opinion of the investigator, may increase risks or may interfere with study participation or interpretation of study resultsXx_NEWLINE_xXSignificant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study resultsXx_NEWLINE_xXSubstance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study results.Xx_NEWLINE_xXAny uncontrolled or significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXAny uncontrolled non-malignant illness that in the opinion of the treating investigator may increase the risks associated with study participation or may interfere with the conduct of the study or interpretation of study results would exclude the participantXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.Xx_NEWLINE_xXConcurrent disease or condition that would make the patient inappropriate for trial participation or any serious medical disorder that would interfere with the patient’s safety.Xx_NEWLINE_xXParticipant has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate participant participation in the clinical study (e.g., chronic pancreatitis, active hepatitis, etc.).Xx_NEWLINE_xXAny severe concurrent disease which, in the judgment of the investigator, would place the patient at increased risk during participation in the studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality or uncontrolled hypertension that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, interfere with protocol compliance, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for enrollment in this study.Xx_NEWLINE_xXAny other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study resultsXx_NEWLINE_xXHas any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial resultsXx_NEWLINE_xXAny other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trialXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.Xx_NEWLINE_xXHave other concurrent severe and/or uncontrolled medical condition that would, in the site Investigator's judgment contraindicate the patient's participation in the clinical studyXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXSevere active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXOther severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study resultsXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.Xx_NEWLINE_xXAny medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.Xx_NEWLINE_xXAny other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social/psychological complicationsXx_NEWLINE_xXAny other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.Xx_NEWLINE_xXAny medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.Xx_NEWLINE_xXAny other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trialXx_NEWLINE_xXSubstance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study.Xx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXClinical judgment by the investigator that the patient should not participate in the studyXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXPatient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study resultsXx_NEWLINE_xXPatient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXComorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (eg, peripheral neuropathy (PN) that is Grade 1 with pain or Grade 2 or higher of any cause).Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXAny other medical intervention or condition which could compromise adherence to study requirements or confound the interpretation of study results.Xx_NEWLINE_xXSevere, concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollmentXx_NEWLINE_xXAny other condition that would, in the investigator's judgment, contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.Xx_NEWLINE_xXIf they have any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXOther severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study resultsXx_NEWLINE_xXOther severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXPatients with other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study are ineligibleXx_NEWLINE_xXAny other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, including but not limited to, infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etcXx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.Xx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the site investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this studyXx_NEWLINE_xXOther severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study proceduresXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.Xx_NEWLINE_xXAny other medical condition (eg, alcohol abuse) or psychiatric condition that, in the opinion of the investigator, might interfere with the subject’s participation in the trial or interfere with the interpretation of trial resultsXx_NEWLINE_xXKnown medical condition that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interferes with the interpretation of safety resultsXx_NEWLINE_xXAny other medical history, including laboratory results, deemed by the investigator likely to interfere with their participation in the study, or to interfere with the interpretation of the resultsXx_NEWLINE_xXHas substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the InvestigatorXx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with the study treatment or interpretation of the study results.Xx_NEWLINE_xXOther severe acute or chronic medical conditions that is active and not well controlled including colitis, inflammatory bowel disease, or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.Xx_NEWLINE_xXCondition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the studyXx_NEWLINE_xXAny serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study Cancer-Related Exclusion CriteriaXx_NEWLINE_xXAny prior or coexisting medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the studyXx_NEWLINE_xXSerious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastrointestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the studyXx_NEWLINE_xXOther medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this studyXx_NEWLINE_xXAny other severe acute or chronic medical or psychiatric condition or laboratory abnormality which, in the judgment of the investigator, would have made the patient inappropriate for entry into this study.Xx_NEWLINE_xXAll other unstable, severe, or chronic medical or psychiatric conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, recent (within the past year) or active suicidal ideation or behavior, known alcohol or drug abuse, or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study proceduresXx_NEWLINE_xXSevere, concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicatedXx_NEWLINE_xXAny condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study dataXx_NEWLINE_xXAny other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the resultsXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXPatients with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol treatment or required observations, interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXOr psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny other major illness that, in the Investigator's judgment, may substantially increase the risk associated with the patient's participation in this study;Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXCondition or situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient’s participation in the study.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis, or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXConcurrent participation in another clinical study that may add additional safety risks and/or confound study results*Xx_NEWLINE_xXAny condition that would interfere with the subject's ability to comply with study instructions or might confound the study interpretationXx_NEWLINE_xXUncontrolled intercurrent illness including, but not limited to, the following:\r\n* Ongoing or active infection, including latent tuberculosis infection,\r\n* Clinically significant gastrointestinal (GI) disease (such as active Crohn’s disease or ulcerative colitis),\r\n* Recent or significant cardiovascular (CV) disease (defined as any major CV event within the previous 6 months including myocardial infarction, unstable angina, cardiac arrhythmia, stroke, pulmonary embolism [PE], or New York Heart Association class III or IV heart failure),\r\n* History of liver function abnormality requiring investigation, drug induced liver injury, chronic liver disease, excessive alcohol consumption or chronic alcohol-induced disease,\r\n* Psychiatric illness/social situations that would limit compliance with study requirements, or\r\n* Any other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXOther severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.Xx_NEWLINE_xXMedical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXPart of another study that may interfere with our outcome of interest, unstable mental conditionXx_NEWLINE_xXPatients must not have current evidence of any condition, therapy, or laboratory abnormality (including active or uncontrolled myelosuppression [ie, anemia, leukopenia, neutropenia, thrombocytopenia]) that might confound the results of the study or interfere with the patient's participation for the full duration of the study treatment or that makes it not in the best interest of the patient to participateXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens; NOTE: this includes uncompensated heart or lung diseaseXx_NEWLINE_xXhave any other medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, that may interfere with the interpretation of study results or that otherwise would, in the opinion of the Investigator, make study participation inappropriate;Xx_NEWLINE_xXOther severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this studyXx_NEWLINE_xXOther severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study.Xx_NEWLINE_xXOther medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results in the judgment of the investigatorXx_NEWLINE_xXEvidence of any other significant clinical disorder or laboratory finding that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXOther severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study resultsXx_NEWLINE_xXSerious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the studyXx_NEWLINE_xXAny other major illness that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in this studyXx_NEWLINE_xXAny other acute or chronic medical or psychiatric condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor, including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAny medical or psychosocial condition that will interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXKnown medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study resultsXx_NEWLINE_xXAny condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study dataXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the studyXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXKnown medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXPatient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAll other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXUncontrolled congestive heart failure (CHF) or other comorbid systemic illnesses or severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXSubject has any concurrent medical condition or disease (eg, active systemic infection, laboratory abnormalities) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this studyXx_NEWLINE_xXKnown medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety resultsXx_NEWLINE_xXOther severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny prior or coexisting medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the studyXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of patient safety or study results.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXHave any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the subject.Xx_NEWLINE_xXAny other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or lab abnormality that may increase the risk associated with study participation, drug administration or may interfere with the interpretation of study results.Xx_NEWLINE_xXAny condition that, in the opinion of the treating investigator would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAny other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study proceduresXx_NEWLINE_xXAny other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etcXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXOther severe acute or chronic medical condition, including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis, or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXHas a condition that, in the opinion of the investigator, would interfere with the evaluation of the study drugs or the interpretation of patient safety or study resultsXx_NEWLINE_xXAny medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results or, is an unsuitable candidate to receive study drug (e.g. inability to tolerate oral medications which would preclude absorption of olaparib)Xx_NEWLINE_xXAny other medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens, e.g. uncontrolled infection (infection requiring systemic antibiotic therapy or other serious infection =< 14 days prior to registration); or uncompensated heart or lung diseaseXx_NEWLINE_xXSerious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the studyXx_NEWLINE_xXPatients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this studyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAny condition that might interfere with the subject’s participation in the study, safety, or in the evaluation of the study resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXThe patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the studyXx_NEWLINE_xXNo co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXA judgment of the investigator that the patient is inappropriate for study participation.Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this studyXx_NEWLINE_xXOther condition, illness, psychiatric condition, or laboratory abnormality that may increase the risk associated with administration of cabazitaxel, study participation, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXClinical judgment by the investigator that the patient should not participate in the studyXx_NEWLINE_xXAny other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXOther severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the studyXx_NEWLINE_xXPHASE I AND II SCLC AND UROTHELIAL CARCINOMA EXPANSION COHORT: Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXUncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations, or other co-morbid systemic illnesses or severe concurrent diseases which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe, acute, or chronic medical condition including uncontrolled diabetes mellitus or psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase risk associated with study participation or may interfere with the interpretation of study resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAny other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.Xx_NEWLINE_xXAny other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient’s ability to sign informed consent or cooperate and participate in the study or with the interpretation of the resultsXx_NEWLINE_xXPatients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this studyXx_NEWLINE_xXPatients with any other severe and/or uncontrolled concurrent disease affecting the cardiovascular system, liver, kidneys, hematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures/results or compromise compliance with the protocol.Xx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication; (patients may not receive drug through a feeding tube), social/psychological issues, etcXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the studyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXCAPMATINIB EXCLUSION CRITERIA: Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study resultsXx_NEWLINE_xXCAPMATINIB EXCLUSION CRITERIA: Any other condition that would, in the Investigator’s judgment, contraindicate patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etcXx_NEWLINE_xXCERITINIB EXCLUSION CRITERIA: Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study or could compromised protocol objectives in the opinion of the Investigator and/or the sponsorXx_NEWLINE_xXREGORAFENIB EXCLUSION CRITERIA: Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study or could compromised protocol objectives in the opinion of the investigator and/or the sponsorXx_NEWLINE_xXENTRECTINIB EXCLUSION CRITERIA: Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study or could compromised protocol objectives in the opinion of the investigator and/or the sponsorXx_NEWLINE_xXSubjects with other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study are ineligibleXx_NEWLINE_xXSubstance abuse or medical, psychological, or social conditions that, in the opinion of the investigator, may interfere with the subject’s participation in the clinical study or evaluation of the clinical study resultsXx_NEWLINE_xXAny other medical issue, including laboratory abnormalities, deemed by the Investigator to be likely to interfere with patient participationXx_NEWLINE_xXHave any other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the principal investigator, would make the patient inappropriate for this studyXx_NEWLINE_xXPatient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study resultsXx_NEWLINE_xXPatient with illness, psychiatric disorder or social issue that could compromise patient safety or compliance with the protocol treatment or procedures, or interfere with the consent, study participation, follow-up, or interpretation of study results.Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify the absorption of oral medications in the small bowel, or any laboratory abnormality that may increase the risk associated with study participation or investigational product administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this studyXx_NEWLINE_xXIndividuals with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXPatients with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or places them at an unacceptable risk for participation in the studyXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study proceduresXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etcXx_NEWLINE_xXPatients must not have any other condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this studyXx_NEWLINE_xXAny coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or resultsXx_NEWLINE_xXAny condition that might interfere with the subject’s participation in the study, compliance with study requirements, or in the evaluation of the study resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participationXx_NEWLINE_xXMedical, psychological, or social conditions that, in the opinion of the investigator, may increase the patient’s risk or interfere with the patient’s participation in the study or hinder evaluation of the study resultsXx_NEWLINE_xXSubstance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study results.Xx_NEWLINE_xXOther co-morbid conditions that, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this studyXx_NEWLINE_xXAny other severe acute or chronic medical or psychiatric condition or laboratory abnormality which, in the judgment of the investigator, would have made the patient inappropriate for entry into this studyXx_NEWLINE_xXPatient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study resultsXx_NEWLINE_xXSubjects with any severe concurrent disease or condition, including significant active autoimmune diseases such as rheumatoid arthritis, which in the judgment of the principal investigator, would make the subject inappropriate for study participationXx_NEWLINE_xXPatients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this studyXx_NEWLINE_xXAny other condition(s) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXSubstance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this studyXx_NEWLINE_xXPatients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study dataXx_NEWLINE_xXAny significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXAny severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and/or with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the subject inappropriate for entry into this trial.Xx_NEWLINE_xXAny concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicitiesXx_NEWLINE_xXAny significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXPatients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study dataXx_NEWLINE_xXOther co-morbid conditions which, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this studyXx_NEWLINE_xXAny other medical history, including laboratory abnormalities, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the resultsXx_NEWLINE_xXPatients with other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study are ineligibleXx_NEWLINE_xXPatients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study dataXx_NEWLINE_xXPresence of other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the subject enrollment inappropriateXx_NEWLINE_xXSubstance abuse, medical, psychological, or social conditions that may interfere with the patient’s participation in the studyXx_NEWLINE_xXAny medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXSignificant co-morbid condition or disease which in the judgment of the principal investigator would place the patient at undue risk or interfere with the studyXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXIntolerance to the investigational product or its excipients, or any condition that would significantly impair and/or prohibit the patient's participation in the study, as per the Investigator's judgment.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the resultsXx_NEWLINE_xXAny condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements, or interfere with interpretation of study results.Xx_NEWLINE_xXPatients with any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results;Xx_NEWLINE_xXAny other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.Xx_NEWLINE_xXHistory or clinical evidence of any surgical or medical condition which the investigator judges as likely to interfere with the results of the study or pose an additional risk in participating.Xx_NEWLINE_xXMajor surgery within 4 weeks prior to initiation of study treatment. Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther medications, or severe acute/chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into the studyXx_NEWLINE_xXAny other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.Xx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study resultsXx_NEWLINE_xXAny condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into the studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study resultsXx_NEWLINE_xXIf they have any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the resultsXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns with clinical study proceduresXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to concerns regarding safety or compliance with clinical study proceduresXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXPatients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:\r\n* Active uncontrolled infection\r\n* Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastrointestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study\r\n* Psychiatric illness/social situations that would limit compliance with study requirements\r\n* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpointsXx_NEWLINE_xXSubstance abuse, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study resultsXx_NEWLINE_xXAny medical, psychological, or social condition that, in the opinion of the treating physician would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXAny medical condition that, in the opinion of the investigator, would interfere with evaluation of the study treatment or interpretation of patient safety or study results.Xx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXPatient has any other condition that would, in the investigators’ judgment, preclude the patient’s participation in the clinical study due to concerns about safety or compliance with clinical study procedures; e.g., infection/inflammation, intestinal obstruction, inability to swallow oral medication, social/psychological complications.Xx_NEWLINE_xXPresence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration (e.g. acidosis, adrenocortical insufficiency, cirrhosis)Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXPatient with any other condition that would, in the Investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, unable to swallow oral medication, social/psychological complicationsXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXAny significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXAny other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medications, social/psychological issues, etc.)Xx_NEWLINE_xXHave any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with the interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the subject.Xx_NEWLINE_xXAny major medical or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXPatient has any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study resultsXx_NEWLINE_xXCo-morbid illnesses or other concurrent disease that, in the judgement of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-upXx_NEWLINE_xXKnown medical condition that, in the investigator’s opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety resultsXx_NEWLINE_xXSubject has a condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the studyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.Xx_NEWLINE_xXSubjects with other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study are ineligibleXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of subject safety or study resultsXx_NEWLINE_xXAny other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the resultsXx_NEWLINE_xXPatients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator’s opinion would be likely to interfere with a patient’s participation in the study, or with the interpretation of the resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXSignificant cardiovascular disease, severe acute/chronic medical or psychiatric\n             condition, or laboratory abnormality that may increase the risk associated with study\n             participation or study drug administrationXx_NEWLINE_xXAny other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, uncontrolled intercurrent illness etc.Xx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXAny significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, study participation, follow up, or interpretation of study researchXx_NEWLINE_xXAny other medical condition (eg, alcohol abuse) or psychiatric condition that, in the opinion of the Investigator, might interfere with the subject’s participation in the trial or interfere with the interpretation of trial resultsXx_NEWLINE_xXAny other condition that would, in the Investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, unable to swallow oral medication, social/psychological complicationsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of patient safety or study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXPatients have a concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients’ safetyXx_NEWLINE_xXAny uncontrolled medical condition or psychiatric disorder which, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study participation or interpretation of individual patient resultsXx_NEWLINE_xXSubject with any medical condition that could preclude subject participation in the study, pose an undue medical hazard, or which could interfere with study results.Xx_NEWLINE_xXAny condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.Xx_NEWLINE_xXOther medications, severe acute/chronic medical or psychiatric conditions, or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, that in the judgment of the investigator would make the subject inappropriate for entry into this studyXx_NEWLINE_xXAny active infection, intercurrent illness, non-healing wound, severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXhave serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this studyXx_NEWLINE_xXCondition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.Xx_NEWLINE_xXSubjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study, or places them at an unacceptable risk for participation in the studyXx_NEWLINE_xXComorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.Xx_NEWLINE_xXCurrent severe acute or uncontrolled chronic systemic disease (e.g. diabetes mellitus) or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.Xx_NEWLINE_xXOther severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study resultsXx_NEWLINE_xXSubject has another condition that, in the opinion of the Investigator and/or Sponsor, would interfere with evaluation of the IMP or interpretation of subject safety or study results;Xx_NEWLINE_xXAny serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the Investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results.Xx_NEWLINE_xXAny severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results.Xx_NEWLINE_xXCondition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the studyXx_NEWLINE_xXPatients with any medical condition, including alcohol or drug abuse or mental incapacity / hypersensitive to the study drug, which in judgment of the investigator will interfere with the patient's participation in the study or evaluation of study resultsXx_NEWLINE_xXPatients who have any of the following severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study are not eligible:\r\n* Uncontrolled diabetes\r\n* Malabsorption\r\n* Resection of the pancreas or upper small bowel\r\n* Requirement for pancreatic enzymes\r\n* Any condition that would modify small bowel absorption of oral medications\r\n* Other laboratory abnormalityXx_NEWLINE_xXAny concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this studyXx_NEWLINE_xXAny other significant medical illness, abnormality, or condition that would make the patient inappropriate for study participation or put the patient at risk.Xx_NEWLINE_xXPsychiatric or addictive disorders or other conditions or unresolved toxicities of prior therapy greater than grade 2 that, in the opinion of the investigator, would preclude the patient from meeting the study requirements, or interfere with interpretation of study results.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this studyXx_NEWLINE_xXAny other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.Xx_NEWLINE_xXany known condition or situation which may put the patient at significant risk, may confound the study results, or may interfere significantly with subject's participation in the studyXx_NEWLINE_xXAny other major illness that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in this study.Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXPatients with concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients’ safetyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of the study medication or interpretation of patient safety or study results.Xx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.Xx_NEWLINE_xXAny concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicitiesXx_NEWLINE_xXPatients with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the protocol principal investigator, excess risk associated with study participation or study agent administrationXx_NEWLINE_xXOther condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study.Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this studyXx_NEWLINE_xXSerious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the studyXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results including known non-compliance issues on study trialsXx_NEWLINE_xXAny new condition or worsening of existing condition that could make the patient unsuitable for participation, or interfere with the patient participating in and/or completing the studyXx_NEWLINE_xXOther severe, acute, or chronic medical or psychiatric condition or laboratory abnormality, that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the principal investigator, would make the patient inappropriate for this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXPatients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the resultsXx_NEWLINE_xXPatients with medical conditions that compromise their ability to complete the study or confound interpretation of study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the local investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, study participation, follow up, or interpretation of study researchXx_NEWLINE_xXAny medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study resultsXx_NEWLINE_xXComorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXPatients exhibiting any other condition that would, in the investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures are not eligible for participation; this might include, but is not limited to, infection/inflammation, intestinal obstruction, and/or social/psychological complicationsXx_NEWLINE_xXInclusion or exclusion of patients on other medications, or severe acute/chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation, or study drug administration, or may interfere with the interpretation of study results will be at the judgment of the study investigatorXx_NEWLINE_xXAny severe acute or chronic medical or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior, liver disease, lung disease (with the exception of what is specified in inclusion criteria), or laboratory abnormalities that, in the opinion of the investigators, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results and in the judgment of the investigator, would make the patient inappropriate for entry into this study; patients with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) well controlled with oral or inhaled medications are permitted to enrollXx_NEWLINE_xXSerious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the studyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this studyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXParticipant has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical study (eg, chronic pancreatitis, etc.).Xx_NEWLINE_xXSubject has a severe concurrent disease, infection or comorbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment.Xx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for enrollment in this study.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXPatient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, contraindicate patient participation in the clinical study (e.g. chronic pancreatitis, chronic active hepatitis, etc.)Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for enrollment in this study.Xx_NEWLINE_xXAny condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study resultsXx_NEWLINE_xXPatient has any severe psychiatric disease that would interfere with participation in the trial as determined by the study investigatorXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease, history of any psychiatric or addictive disorder, or laboratory abnormality, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social/psychological complicationsXx_NEWLINE_xXAny other medical condition (eg, alcohol abuse) or psychiatric condition that, in the opinion of the investigator, might interfere with the subject’s participation in the trial or interfere with the interpretation of trial resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this studyXx_NEWLINE_xXAny condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study resultsXx_NEWLINE_xXPatients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this studyXx_NEWLINE_xXComorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause).Xx_NEWLINE_xXCondition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the studyXx_NEWLINE_xXUncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant cardiac and pulmonary disease; liver diseases such as cirrhosis, chronic active or persistent hepatitis; or acute/chronic medical/psychiatric illness/social situations or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or limit compliance with study requirements, or interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study proceduresXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXAny other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the resultsXx_NEWLINE_xXSevere concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollmentXx_NEWLINE_xXAny condition that, according to the investigator, would make the patient an inappropriate study candidate.Xx_NEWLINE_xXSevere acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but is not limited to the following:Xx_NEWLINE_xXPatients exhibiting any other condition that would, in the investigator’s judgment, preclude patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures are not eligible for participation; this might include, but is not limited to, infection/inflammation, intestinal obstruction, and/or social/psychological complicationsXx_NEWLINE_xXSevere concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollmentXx_NEWLINE_xXCondition or situation which, in the investigator’s opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant’s participation in the studyXx_NEWLINE_xXAny prior or co-existing medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent medical conditions that in the judgment of the investigator would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety of the prescribed regimensXx_NEWLINE_xXSubject has severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment.Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXParticipants with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the participant's ability to sign the informed consent form or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the resultsXx_NEWLINE_xXAny concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicitiesXx_NEWLINE_xXPatients with concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients’ safetyXx_NEWLINE_xXCondition or situation which, in the investigator’s opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant’s participation in the studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXSevere concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollmentXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this studyXx_NEWLINE_xXAny prior or co-existing medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the studyXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXSubstance abuse, medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXComorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause)Xx_NEWLINE_xXOther conditions or circumstances that could interfere with the studyXx_NEWLINE_xXSubjects with other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study are ineligibleXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXPatients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.Xx_NEWLINE_xXPatients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the resultsXx_NEWLINE_xXAny significant concurrent psychiatric disorder or social situation that according to the investigator´s judgement would compromise patient´s safety or compliance, interfere with consent, study participation, or interpretation of study results.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXComorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause).Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient’s safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trialXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.Xx_NEWLINE_xXUncontrolled intercurrent illness, including, but not limited to, psychiatric illness/social situations, that in the opinion of the investigator may increase the risks associated with study participation or study treatment, or may interfere with the conduct of the study or the interpretation of the study resultsXx_NEWLINE_xXSignificant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXMedical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study or, in the judgment of the investigator, would make the patient inappropriate for study participationXx_NEWLINE_xXPatients with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administrationXx_NEWLINE_xXE 13. Any severe acute or chronic medical condition which could impair the ability of the participant to participate to the study or interfere with interpretation of study results, or participants unable to comply with the study procedures.Xx_NEWLINE_xXPatients with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this studyXx_NEWLINE_xXSubstance abuse, medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXSevere concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollmentXx_NEWLINE_xXSevere concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollmentXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results; subjects with uncontrolled seizuresXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the subject inappropriate for entry into the studyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXOther severe acute or chronic medical condition, uncontrolled intercurrent illness or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial; uncontrolled intercurrent illness includes, but is not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirementsXx_NEWLINE_xXPatients must not have any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient’s ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the resultsXx_NEWLINE_xXMedical, psychological, or social conditions that, in the opinion of the investigator, may increase the patient’s risk or interfere with the patient’s participation in the study or hinder evaluation of the study resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study resultsXx_NEWLINE_xXPatients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.Xx_NEWLINE_xXHistory of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirementsXx_NEWLINE_xXSubstance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.Xx_NEWLINE_xXPatients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.Xx_NEWLINE_xXAny major medical or psychiatric disorder that in the opinion of the investigator prevent the subject from completing the study or interfere with the interpretation of the study resultsXx_NEWLINE_xXAny significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXPatients with any severe, progressive or uncontrolled acute or chronic medical condition (such as uncontrolled infectious disease or sepsis) or clinical laboratory abnormalities that in the investigator's opinion would make the patient inappropriate for entry into this study (at screening or baseline).Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this studyXx_NEWLINE_xXSevere concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollmentXx_NEWLINE_xXAny disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests and ECG), that in medical judgment of the investigator may impede the participant's participation in the study, pose increased risk to the participant, and/or confound the results of the studyXx_NEWLINE_xXAny other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etcXx_NEWLINE_xXAny prior or coexisting medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the studyXx_NEWLINE_xXAny disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests, ECG), that in medical judgment of the investigator may impede the subject's participation in the study, pose increased risk to the subject, and/or confound the results of the studyXx_NEWLINE_xXSevere concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment.Xx_NEWLINE_xXPatients have a concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients’ safety as determined by the investigatorXx_NEWLINE_xXSerious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the studyXx_NEWLINE_xXMedical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk, interfere with the patient’s participation in the study, or hinder evaluation of study resultsXx_NEWLINE_xXOther medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this studyXx_NEWLINE_xXConcurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safetyXx_NEWLINE_xXAny other medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the resultsXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXHas any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of the study results and, in the Investigator's opinion, would make the subject inappropriate for entry into this study.Xx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXAny severe, acute or chronic medical or psychiatric condition, or lab abnormality that may increase the risk associated with trial participation, study drug administration or interfere with informed consent process or compliance with requirements of the trial.Xx_NEWLINE_xXhave any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study.Xx_NEWLINE_xXHave any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results.Xx_NEWLINE_xXHistory of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation of investigational product(s) administration or may interfere with the interpretation of the resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study resultsXx_NEWLINE_xXPatients with substance abuse, medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the patient’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXPatients must not have a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the resultsXx_NEWLINE_xXPatients with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patient’s ability to sign the ICF or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the resultsXx_NEWLINE_xXPresence of any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny medical disorder that, in the option of the investigator, might increase the risk associated with study participation or interferes with the interpretation of study resultsXx_NEWLINE_xXSevere acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational device administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into thisXx_NEWLINE_xXPatients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.Xx_NEWLINE_xXHave serious pre-existing medical conditions (at the discretion of the investigator, such as severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation).Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this studyXx_NEWLINE_xXAny other acute or chronic medical or psychiatric condition (including alcohol and illicit substance abuse) or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of the study results and, in the judgment of the Investigator or Medical Monitor, would render the subject inappropriate for participation in the study.Xx_NEWLINE_xXAny other significant medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this studyXx_NEWLINE_xXPatients with any other condition that would, in the judgment of the investigator, put the patient at increased risk during participation in the study, or interfere with the conduct of the study.Xx_NEWLINE_xXClinical or laboratory signs and symptoms of significant cerebral, cardiovascular, respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the Investigator's judgment may interfere with the study assessment or completion of the study.Xx_NEWLINE_xXPatients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.Xx_NEWLINE_xXAny other severe acute or chronic medical or psychiatric condition or test abnormality(ies) that, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the studyXx_NEWLINE_xXAny other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny medical condition that in the investigator’s opinion could interfere with interpretation of study or toxicity, or increase the risk to the patient related to potential toxicityXx_NEWLINE_xXPatients with serious illnesses, medical conditions, or other medical history, including a prior history of pericarditis/pericardial effusion, or abnormal laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the resultsXx_NEWLINE_xXSubstance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study resultsXx_NEWLINE_xXHistory of other malignancies in the last 5 years, in particular those that could interfere with interpretation of results.Xx_NEWLINE_xXAny other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the resultsXx_NEWLINE_xXPatients with concurrent uncontrolled medical conditions that may interfere with their participation in the studyXx_NEWLINE_xXAny severe acute or chronic medical condition, which could impair the ability of the patient to participate to the study or to interfere with interpretation of study resultsXx_NEWLINE_xXSubstance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study results.Xx_NEWLINE_xXOther medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results in the judgment of the investigatorXx_NEWLINE_xXCurrent or past substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.Xx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXAny condition that might interfere with the subject's participation in the study or in the evaluation of the study results.Xx_NEWLINE_xXConcurrent cardiac disease that, in the judgment of the Investigator, would make the patient inappropriate for study participation.Xx_NEWLINE_xXPatients with any other medical or psychological condition deemed by the investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study.Xx_NEWLINE_xXAny disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s), that in medical judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the studyXx_NEWLINE_xXAny medical, psychological, or social conditions, particularly if unstable, including substance abuse, that may, in the opinion of the Investigator, interfere with the subject's safety or participation in the study, protocol compliance, or evaluation of the study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the prescribed regimensXx_NEWLINE_xXSignificant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise the subject's safety or compliance or interfere with interpretation of study results.Xx_NEWLINE_xXPatients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this studyXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study result.Xx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this studyXx_NEWLINE_xXPatients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the resultsXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study resultsXx_NEWLINE_xXAny significant concurrent disease, illness, or psychiatric disorder that would compromise participant safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study resultsXx_NEWLINE_xXConcurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the patient's safety or compliance to study procedures;Xx_NEWLINE_xXany severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administrationXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny condition that, in the opinion of the local/lead site PI, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXSerious medical or psychiatric illness likely to interfere with participation in this clinical study; other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation, or investigational product administration, or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXOther severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this studyXx_NEWLINE_xXPatient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study resultsXx_NEWLINE_xXSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny other condition that would, in the Investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.Xx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny of the following co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens:\r\n* History of myocardial infarction\r\n* Unstable angina\r\n* Left ventricular hypertrophy\r\n* Mitral valve prolapse syndromeXx_NEWLINE_xXConcurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient’s safetyXx_NEWLINE_xXAny significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, study participation, follow up, or interpretation of study researchXx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study resultsXx_NEWLINE_xXPatients must not have any condition or situation which, in the investigator’s opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient’s participation in the study.Xx_NEWLINE_xXAny significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study resultsXx_NEWLINE_xXAny other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics)Xx_NEWLINE_xXAny other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/psychological issues, etcXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/psychological issues, etcXx_NEWLINE_xXOther acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this studyXx_NEWLINE_xXAny other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/ psychological issues, etcXx_NEWLINE_xXOther severe, acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or, in the judgment of the investigator, would make the patient inappropriate for the studyXx_NEWLINE_xXPresence of psychiatric or psychological symptoms which in the judgment of the principal or associate investigators would compromise the donor’s ability to engage in the intervention or is likely to interfere with the study procedures or resultsXx_NEWLINE_xXOtherwise considered inappropriate for the study by the Investigator.Xx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy or interfere with the interpretation of study resultsXx_NEWLINE_xXSignificant co-morbid condition or disease which in the judgment of the principal investigator would place the patient at undue risk or interfere with the studyXx_NEWLINE_xXAny medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results. Conditions include but are not limited to:Xx_NEWLINE_xXMedical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXParticipants who, in the judgment the study principal investigator (PI), have severe or unstable mental illness which could interfere with participation in the trialXx_NEWLINE_xXAny major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study resultsXx_NEWLINE_xXPatients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study dataXx_NEWLINE_xXAny serious, uncontrolled comorbidity or condition that an Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient Intraoperative Exclusion CriteriaXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXPatients with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXRECIPIENT: Any other condition that would, in the investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/ psychological issues, etcXx_NEWLINE_xXAny condition or situation which in the investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the studyXx_NEWLINE_xXCo-medication that may interfere with study results; e.g., immune-suppressive agents other than corticosteroidsXx_NEWLINE_xXSevere active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXPatient has a medical, psychiatric or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study resultsXx_NEWLINE_xXAny other medical condition(s) that, in the judgment of the Site Investigator, might interfere with the study or require treatment that might interfere with the studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole-breast irradiation (such as connective tissue disorders, lupus, or scleroderma)Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study resultsXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Study participation or investigational product administration or may interfere with the interpretation of Study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this Study.Xx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study resultsXx_NEWLINE_xXAny other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study proceduresXx_NEWLINE_xXSevere concurrent disease, infection, or medical co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollmentXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would interfere with the interpretation of study results or subject safety including non-malignant FDG avid diseases such as sarcoidosis or other granulomatous diseaseXx_NEWLINE_xXAny past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the studyXx_NEWLINE_xXSubstance abuse, medical, psychological, or social conditions that may interfere with the patient’s participation in the studyXx_NEWLINE_xXCondition or situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient’s participation in the studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAny medical condition that would in the investigator's judgment interfere with full participation in the study, including administration of study medication and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.Xx_NEWLINE_xXHas substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study resultsXx_NEWLINE_xXSignificant co-morbid condition or disease which in the judgment of the principal investigator would place the patient at undue risk or interfere with the studyXx_NEWLINE_xXOther severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXCo-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimensXx_NEWLINE_xXAll other unstable, severe, or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this studyXx_NEWLINE_xXOther severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this studyXx_NEWLINE_xXAny other condition that would, in the investigator’s judgment, contraindicate patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g. infection/inflammation, intestinal obstruction, social complicationsXx_NEWLINE_xXSubstance abuse, medical, psychological, or social conditions that may interfere with the patient’s participation in the studyXx_NEWLINE_xXAny other disease or medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this studyXx_NEWLINE_xXOther severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administrationXx_NEWLINE_xXCo-morbid systemic illnesses such as active infection or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens; NOTE: patients with significant gut malabsorptive conditions (such as inflammatory bowel disease or others at the discretion of the investigator) will be excludedXx_NEWLINE_xXSubstance abuse or medical conditions such as clinically significant cardiac or pulmonary diseases or psychological conditions, that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.Xx_NEWLINE_xXOther severe acute or chronic medical (may include severe gastrointestinal conditions such as chronic diarrhea or ulcer disease) or psychiatric conditions, or laboratory abnormalities that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of the study results and, in the judgment of the investigator, would make the patient inappropriate for study entry.Xx_NEWLINE_xXAny other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.Xx_NEWLINE_xXCo-medication or concomitant therapy that may interfere with study resultsXx_NEWLINE_xXAny other significant medical illness, abnormality, or condition that would make the patient inappropriate for study participation or put the patient at risk.Xx_NEWLINE_xXOther severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this studyXx_NEWLINE_xX