Current participation in another therapeutic clinical trial
Current treatment or participation on another therapeutic clinical trial
Current treatment on another therapeutic clinical trial
Concurrent participation in another therapeutic clinical trial
Concurrent enrollment in another therapeutic clinical trial.
Current participation in another clinical trial of a drug or device or past participation within 4 weeks before Baseline or subject is in exclusion period from a previous clinical trial
Concurrent participation in another therapeutic clinical trial.
Is participating in another therapeutic clinical trial
Enrollment into another therapeutic clinical trial.
Concurrent participation in another therapeutic or imaging clinical trial.
Concurrent participation in another therapeutic treatment trial
Current treatment on another therapeutic clinical trial
Concurrent participation in another therapeutic clinical trial.
Simultaneous participation in other therapeutic clinical trials will not be allowed
CAPMATINIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
CERITINIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
REGORAFENIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
ENTRECTINIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
Simultaneous participation in other therapeutic clinical trials will be allowed
Current treatment on another therapeutic clinical trial
Concurrent participation in another therapeutic clinical trial
Concurrent treatment with any other anti-neoplastic drug or concurrent participation in another therapeutic clinical trial
Concurrent treatment with any other anti-neoplastic drug or concurrent participation in another therapeutic clinical trial
Current treatment on another clinical trial; participation in non-therapeutic clinical trials is permissible
Participation in another clinical trial within 4 weeks
Current treatment on another therapeutic clinical trial
Current participation in another therapeutic clinical trial.
Major surgical intervention or participation in a therapeutic clinical trial within 28 days from Day 1 of the first dose of MSC2363318A
Current treatment on another therapeutic clinical trial
Concurrent participation in another therapeutic clinical trial.
Participation in any other clinical trial
Treatment on another therapeutic clinical trial within 4 weeks of enrollment in this trial
Simultaneous participation in other therapeutic clinical trials will not be allowed
Current treatment on another therapeutic clinical trial
concurrent treatment on another therapeutic clinical trial
Concurrent participation in another therapeutic clinical trial
Concurrent participation in another therapeutic clinical trial;
Concurrent participation in another therapeutic clinical trial
Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
Current treatment on another therapeutic clinical trial
Current participation in another drug trial
Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment
Participation in a therapeutic research trial within the past three months
Actively participating in another therapeutic clinical trial
Simultaneous participation in other therapeutic clinical trials will not be allowed
Concurrent participation in another therapeutic treatment trial.
Concurrent participation in another therapeutic clinical trial.
Participation in a therapeutic clinical trial
Concurrent participation in another clinical trial
Current enrollment in a therapeutic clinical trial
Current treatment on another therapeutic clinical trial
Patients must be enrolled within 1 year after diagnosis
Patients currently enrolled in other clinical trials testing a therapeutic intervention
Patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation
Subjects currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug
Patients may not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy
EXPANDED ACCESS COHORT: Participants must be currently enrolled to DFCI protocol number 13-506 or discontinued from protocol 13-506 solely because the study agents were no longer available via protocol 13-506
Note: Patients may be enrolled more than once (e.g., for a new tumor)
Patient is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug
Currently enrolled in a clinical study.
Patient is receiving or plans to receive other investigational therapy and/or is enrolled or plans to enroll in a separate clinical study.
Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic's study manager to determine if the subject can be enrolled in both studies.
Currently enrolled in another interventional study.
Currently enrolled in another investigational therapy protocol for AML.
Consent for tumor biopsies (for patients enrolled in stage 1 only) and blood draws for research purposes (for all patients)
Previously enrolled in the present study
If you are pregnant, you will not be enrolled on this study
Currently enrolled in another clinical trial.
Patients who are simultaneously enrolled in any other treatment study
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
PART 2: Meeting criteria for 1st phase as above, at time of initiation of JAK inhibitor, including ability to understand and willingness to sign a written informed consent; patients arriving to our institution for transplant and not enrolled in Part 1 may still be enrolled in Part 2 if Part 1 criteria met; these patients will have Part 1 endpoints transcribed from medical records
Shares the same address as a currently enrolled participant
Patients who are simultaneously enrolled in any other treatment study
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of ruxolitinib that has completed or been terminated.
Subjects cannot be simultaneously enrolled on other treatment studies
Previously enrolled in this study.
Previous or concurrent cancer that is distinct from tumor for which the patient is enrolled in study, with exceptions
Currently enrolled in a Valor-sponsored IGN002 study
Participation in other investigational studies while enrolled on this trial.
RENAL & BLADDER: Currently enrolled in another interventional study
Enrolled in another clinical trial with a targeted endpoint of treating the patient’s cancer (observational trials are acceptable)
Only patients with tumors that score positive in the in vitro organoid bio-assay will be enrolled in the clinical trial; patients with tumors that score negative in this bio-assay will be considered screening failures and will not be enrolled in the clinical trial
Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123; patients must be enrolled within 31 days of definitive diagnostic surgery (day 0) or clinical diagnosis
FOR PATIENTS IN STAGE 2 (ENROLLED PATIENT #18 AND BEYOND)
Subjects who have recently been enrolled in other experimental clinical trials of\n             investigational agents
Patients must be enrolled within 56 weeks following completion of therapy
Patients who are currently receiving chemotherapy, radiation therapy or are enrolled in another therapeutic clinical trial
If patient goes on to have an open thoracotomy as part of surgical treatment they will not be enrolled
Patients enrolled on another therapeutic study
Patients must be enrolled between 8 to 20 weeks post OLT
Subject is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.
Hepatitis B + patients may be enrolled at the discretion of the investigator
Currently enrolled in study CCL09101E, or YM387-II-02, or successfully completed 24 weeks of study GS-US-352-1672
Are currently enrolled in another clinical trial.
Organ function requirements are not required for enrolled patients who are stage I, PFH and will not be receiving chemotherapy
For patients with EOC enrolled in the single agent expansion stage:
Patients who are currently enrolled on another clinical trial
Patients enrolled in other clinical trials must have received their last treatment at least 6 weeks prior to enrollment
Currently enrolled in other professional tobacco cessation therapeutic intervention
Patients who are simultaneously enrolled in other treatment studies
Are currently enrolled or discontinued less than 14 days from another clinical trial
Patients who are enrolled in other symptom management or symptom clinical trials
Exclusion criteria below (*) apply only to patients who are enrolled AFTER completing 3 to 6 cycles of first-line chemotherapy; exclusion criteria (*) DO NOT APPLY to patients who are enrolled prior to completing 3 to 6 cycles of first-line chemotherapy; these patients can be enrolled but ultimately MAY not be treated with radiation therapy/SBRT; this is dependent on their restaging imaging after the completion of chemotherapy
Patients who are enrolled in a national/international cooperative group trials
Patients must have been enrolled, or agree to consent to the companion genomic profiling study MSKCC IRB# 12-245; results must be available before starting treatment on protocol
Be currently enrolled in another investigational treatment protocol
Patients who have received prior treatment with antiCTLA-4 may be enrolled, provided the following requirements are met:
Subject is enrolled in any other clinical protocol or investigational trial with an interventional agent or assessments that may interfere with study procedures.
Previously or currently enrolled in Protocol No. TPI-287-17
Patient is enrolled in any other therapeutic clinical protocol or investigational trial
Patients enrolled must, in the Investigator's judgment, be healthy enough to stay on the clinical trial for three months.
Patient is enrolled in any other therapeutic clinical protocol or investigational trial
Be currently enrolled in another investigational protocol
Patients must have been enrolled, or agree to consent to the companion genomic profiling study MSKCC IRB# 12-245
Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices.
Patients enrolled into phase Ib may be enrolled with evaluable disease only. Patients enrolled into the phase II expansion must have at least one measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
Donor must not be currently enrolled on another investigational agent study.
Currently enrolled in another interventional study
Patients currently enrolled in another study; concurrent enrollment in another study is prohibited expect for the control arm which can be used for other protocols with HRQOL endpoints with similar instruments
Be planning to start yoga on their own during the time they are enrolled in the study
Another household member enrolled in the study
Currently already enrolled on the TrueNTH website
Patients enrolled on another clinical trial which prohibits the use of pre-phase therapy or any of its components
Enrolled on a phase I trial
Patient is currently enrolled in hospice
101 Subject was previously enrolled in Study 20062004.
Patients enrolled in other CGA studies will not be excluded
Patients currently enrolled onto therapeutic cancer clinical trial(s) involving non-standard cancer drugs
Participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials
Patients currently enrolled on Children's Oncology Group (COG) study ACCL0934 are not eligible until they have completed the infection observation period of that study
Patients previously enrolled on this trial are ineligible
Patients previously enrolled on the trial are not eligible; therefore, patients with AL who were on study during intensive chemotherapy are not eligible to be enrolled during the HSCT
Patients currently enrolled on the ACCL1034 study are not eligible until they have completed the 90 day observation period of that study
Currently enrolled in a physical therapy course
Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention
ONCOLOGIST: Have a patient panel that will allow for >= 6 eligible patients to be enrolled in the study
Patients enrolled on other supportive care intervention trials
Subjects must be already enrolled in P.R.O.G.E.C.T observational registry (HSC #12614)
Individuals who are enrolled on oral chemotherapy clinical trials will also be excluded
Two discretionary enrollment criteria include:\r\n* Patients with ductal breast carcinoma in situ (DCIS) may be enrolled into the study if they are eligible for and considering either mastectomy or BCS with radiation\r\n* Patients taking neoadjuvant chemotherapy may be enrolled into the study if they are eligible for and considering either mastectomy or BCS
Patients who are enrolled in other clinical trials that have symptom management as primary outcome
Has another family member already enrolled in ICCAN (as determined by patient report)
Patients who are enrolled in other symptom management clinical trials
Patients who are enrolled in another symptom management trial
Are enrolled in any other cancer prevention/outreach related study
No patients will be enrolled that require sedation for the MRI
enrolled in a competing study; and
BETA/USABILITY TESTING: Will have been enrolled for year prior to the mammogram at Group Health
Another household member being enrolled in the study.
Individuals enrolled in or who plan to enroll in a clinical intervention trial; there must be a 30-day period between completing a previous study and enrolling in this study; the principal investigator will have the option to consider an exception for patients on drugs of interest for the purpose of this study
Currently enrolled in an ‘in-person’ cessation program
Patients with pT3a disease who lack one of the above criteria, and who refuse adjuvant radiation, may also be enrolled
Pregnant women are excluded from this study; patients enrolled in the study must be able to undergo intensive RT plus or minus chemotherapy
Another household member enrolled in the study
Currently enrolled at Salish Kootenai College
Currently enrolled on an interventional investigational study
Patients enrolled on another investigational trial for oral mucositis prevention
Another household member enrolled in the study
Participants who are already enrolled in a conflicting investigational trial
Enrolled in study part #1
Enrolled in any other clinical studies the investigator believes to be in conflict with this investigation
Patients who are not enrolled in the OCSP
Urinalysis abnormalities will not preclude the patient from being enrolled and studied
Patients preparing to receive therapy for pancreas cancer, including patients enrolled in HRPO# 201201124 or other clinical trials, are eligible
Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed; patients may be enrolled to other clinical trials after completing all of the baseline interventions and measures
Enrolled in hospice
Currently enrolled in protocol 2014-0712 (PCS study)
Patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
RANDOMIZED PHASE II CLINICAL TRIAL: Patients participating in another trial of an investigational agent within 4 weeks of the first dose of the study
RANDOMIZED PHASE II CLINICAL TRIAL: Subjects who do not consent to providing pre and post treatment tissue sample for future research would not be eligible to participate in the trial
No concurrent treatment on another clinical trial; supportive care trials or nontreatment trials, e.g. quality of life, are allowed
Clinical Laboratories:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Enrolled in another clinical trial testing a novel therapy or drug within the past 4 weeks.
Is currently receiving tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical trial or any other clinical trial being conducted with tazemetostat that is not sponsored by Epizyme (including but not limited to, Investigator initiated trials). For subjects on combination therapy, the other therapeutic(s) must have been completed or will be provided by a source other than Epizyme
Patients may not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy; (Note: patients on the standard therapy arm of another GBM trial that otherwise meet eligibility requirements for this trial remains eligible for cohort 1)
Previous clinical trial enrollment is allowed
Patients participating in a clinical trial where prevention of GVHD is the primary endpoint.
Concurrent use of other investigational drugs or treatment in another clinical trial with a non-FDA-approved medication within the past 4 weeks before start of therapy
Actively participating in another clinical treatment trial
Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 4 weeks of the first dose of trial treatment.
Male breast cancer patients. 19. Patients may not be on a concurrent clinical trial, unless approved by Investigator.
Patients must have life-expectancies > 6 months to be included in the trial
Patients voluntarily participate in the clinical trial, understanding they may withdraw participation at any time
Patients who were enrolled into any other treatment clinical trial and received treatment on that trial within 4 weeks of study treatment
Have participated in a prior oregovomab clinical trial. Prior treatment with Hiltonol® does not exclude a subject from participation.
Symptoms of a clinically significant illness that may place the subject at risk by trial participation or influence the outcome of the trial in the four weeks before first treatment and during the trial;
Participation in the treatment phase of another clinical trial within the four weeks prior to treatment in this clinical trial;
Participated within the last 30 days in a clinical trial.
Patients may not be on a concurrent clinical trial, unless approved by PI.
No clinical symptoms of hypothyroidism
IMMUNE RECONSTITUTION STUDY ONLY: Decline to participate in the main trial, or main trial closed to accrual due to safety review
Patients may not be receiving the treatment targeting the activated gene as part of a clinical treatment trial other than the Precision Oncology Trial
Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
Enrolled on another clinical trial testing a novel therapy or drug
Current treatment on another clinical trial
Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial
Clinical T-classification T1-3
Clinical T4 disease
Patients must have at least one lesion which can be biopsied with acceptable clinical risk as judged by the clinical services who perform the biopsy
Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
Participation in another clinical trial with drugs received within 3 months prior to dosing (calculated from the previous study's last dosing date).
Patients are excluded from this trial if they have melanoma, small cell carcinoma, lymphoma/leukemia, or germ cell histology (note, melanoma patients will be eligible for the sister trial to this trial which will be open simultaneously)
Clinical stages T3-4 disease
Currently participating in another clinical trial using an investigational study medication, or recent participation in such a trial
Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.
Use of GSK2315698 (CPHPC), or participation in a separate clinical trial involving CPHPC within 3 months of screening
Are participating or have participated in another clinical trial for the palliation of their targeted bone metastasis tumors in the last 30 days
Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.
Currently participating in another clinical trial
History of previous malignancy that in the principal investigator (PI)’s opinion has a reasonable chance of recurrence during the study period or otherwise confounding this clinical trial
Any other experimental treatment on another clinical trial
Participation in any other ongoing ceftolozane/tazobactam trial
THE PATIENT IS INELIGIBLE TO PARTICIPATE IN PART 2 IF ANY OF THE FOLLOWING OCCUR: Any other exclusion criteria set forth by individual treatment protocol of the active clinical trial(s) through which patients are going to be treated.
The trial is open to both genders
Participation in a clinical trial using immunological experimental therapy (e.g. monoclonal antibodies, cytokines or active cellular immunotherapies) within the last 6 months prior to randomization
Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. quality of life (QOL), are allowed
Patients whose entry to the trial will cause unacceptable clinical delays in their planned management
Current treatment with any systemic anti-cancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
Have a clinical indication for treatment as determined by the investigator
The trial is open to both genders
Currently enrolled in another clinical trial (exclude non-cancer treatment trial) or received an investigational agent within 4 weeks of study initiation
A clinical indication for treatment as determined by the investigator
Use of any investigational drug within 4 weeks before start of trial treatment or concomitantly with this trial.
Patients (at institutions listed) must be offered the opportunity to participate in the optional S1406 Co-Clinical PDX Model trial; participating patients must have a fresh tissue biopsy for the Co-Clinical PDX Model Trial completed within 7 days of Step 2 Randomization
Patients must not be participating in any other therapeutic clinical trial or taking any other experimental medications within 14 days prior to registration
Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. quality of life (QOL), are allowed
Prior treatment in clinical trial UTX-TGR-304
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial
Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
Eligibility to a higher priority trial for first line or recurrent endometrial cancer (unless patient is unwilling to participate in such a trial)
Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. quality of life (QOL), and imaging trials, are allowed
The patient was informed about the positive survival results of the RTOG 96-01 clinical trial, and has elected to forgo treatment with high-dose bicalutamide
PART A: Able (physically and financially) to travel to University of Colorado for clinical trial treatment
Enrolled on another clinical trial testing a novel therapy or drug
Concurrent treatment on another clinical trial; supportive care trials or non-treatment (i.e. quality of life) are allowed
Breast-feeding should be discontinued if a nursing mother is to be treated on clinical trial
Participation in another clinical trial unless approved by the lead principal investigator
Patients with nervous system tumors associated with NF2 (e.g., schwannomas, meningiomas, ependymomas, or gliomas) will not be excluded from this clinical trial unless (in the opinion of the investigator) these tumors are growing and are likely to require treatment during the clinical trial
Any treatment in a BMS-936558 (Nivolumab) trial
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial
Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. quality of life (QOL), are allowed
Current treatment on another clinical trial
Patient participating in another clinical trial or receiving an investigational drug
Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
Concurrent treatment on another clinical trial; supportive care trials, surgical clinical trials, or non-treatment trials, e.g. quality of life (QOL), are allowed
Any previous treatment with study drug (RO5185426) or participation in a clinical trial that includes RO5185426
Has been withdrawn from the CS35 trial.
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
Receipt of investigational therapy in a clinical trial setting within 30 days of enrollment;
Was enrolled on the Phase 1 clinical trial ONT-10-001 and:
Clinical Laboratories:
Patient has not previously participated in any clinical trial of iniparib.
Prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol).
current treatment in another clinical trial
Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
Patients who previously participated in or are currently participating in another intervention clinical trial designed to improve adherence
Are participating or have participated in another clinical trial in the last 30 days
Concurrent treatment on another clinical trial; supportive care trials or non-therapeutic trials (i.e. quality of life) are allowed
Active treatment on another clinical trial.
Patients whose participation in this trial would require exclusion from participation in another clinical research trial related to the patient's malignant diagnosis
Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial
Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation)
Enrolled on a therapeutic or supportive care clinical trial
For the part 2 randomized controlled trial (RCT), participated in part 1, step 1 or 2
Lactating patients must agree not to nurse a child while on this trial
TRIAL SUBJECTS:
Participants will have no previous history of clinical trial research participation
Ability to give informed consent before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
Subject has previously participated in any clinical trial with the investigational device.
Discontinued from study treatment from another clinical trial within 28 days prior to randomization.
Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial
Note: Patients who enroll in hospice during the trial will have the option of continuing trial participation
All patients who are receiving chemotherapy and/or radiation therapy are eligible for study if they have completed > 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist; the principal investigator (PI)/designated research staff of this study will obtain and document approval from the primary oncologist and principal investigator of the clinical trial in case the patient is on another clinical trial as referenced in the patient's study documents
All patients who are receiving chemotherapy and/or radiation therapy are eligible for study if they have completed at least one cycle of chemotherapy or targeted therapy, or > 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist; the principal investigator (PI)/designated research staff of this study will obtain and document approval from the primary oncologist and principal investigator of the clinical trial in case the patient is on another clinical trial as referenced in the patient's study documents
Patients are not required to be registered on a COG therapeutic trial
Patients are permitted to participate in other clinical trials while participating in this trial
Current daily application of a prescribed topical product to the skin within the RT area for an unrelated skin condition that cannot be discontinued during the participation in this clinical trial
Participants must have been informed of their eligibility for a specific phase II or III therapeutic clinical trial open for enrollment at the participating National Cancer Institute (NCI) Community Oncology Research Program (NCORP) site
Participants must not have been asked previously to participate in another therapeutic cancer clinical trial
Participation of patients on other clinical trial protocols permitted, if not prohibited by trial guidelines
CLINICAL PROCOTOL USED AS REFERENCE FOR THIS STUDY:
RANDOMIZED CONTROL TRIAL:
Individuals must not currently be participating in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only; patients must also agree not to join such a trial while participating in this study
Previous participation in any clinical trial involving rolapitant
Patient’s deemed otherwise clinically unfit for clinical trial per investigator’s discretion
Must not participate in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only. Participants must also agree not to join such a trial while participating in this study.
Have participated in any clinical trial in the previous 30 days.
Patients receiving active therapy on an investigational trial at the time of enrollment should consult with the study chair regarding potential interactions with other study agents; patients who are enrolled in a clinical trial but are off-therapy and in follow up are eligible
The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol
Enrollment into this study may occur in tandem with other clinical therapeutics trials occurring at Vanderbilt University Medical Center (VUMC) as long as this trial does not violate protocol or inclusion criteria of that study
Intention to enroll in a blinded therapeutic clinical trial
Subject must have a life expectancy that exceeds the duration of the clinical trial
Participating in a concurrent clinical trial or has participated in another clinical trial with an investigational compound within the past 30 days
Have not participated in a clinical trial before
Inclusion:\n\n          -  21 years of age or older\n\n          -  Have a cancer diagnosis\n\n          -  Self identify as African American\n\n          -  Therapeutic Phase I, II or III clinical trial at Massey Cancer Center (regardless of\n             whether or not they join the therapeutic trial)\n\n          -  Be able to provide informed consent\n\n          -  We will also recruit one family member/caregiver (N = 357) of each participating\n             patient\n\n          -  Consented patients will not be excluded from this study if their family member\n             declines to participate by completing the Cancer Communication Assessment Tool for\n             Families (CCAT-F).
Inclusion:\n\n        A parent trial must :\n\n          -  have a coordinating Center willing to allow their Clinical Sites to participate;\n\n          -  be studying be studying a condition that requires community or health system physician\n             referral\n\n          -  be studying an intervention where the recruitment approach cannot be made directly to\n             minority community members\n\n          -  need to increase recruitment of racially/ethnically diverse participants* to the trial\n             as demonstrated by current trial progress or historical data from other trials in the\n             same disease;\n\n          -  be a Phase II or Phase III trial\n\n          -  be conducted in at least six multiple sites;\n\n          -  expect each Clinical Site to recruit at least 10 participants;\n\n          -  be funded by a sponsor (NIH or pharmaceutical company or other) that has a strong\n             commitment to recruiting racially/ethnically diverse subjects;\n\n          -  be willing to have investigators and coordinators attend a special training meeting\n             (at RECRUIT expense);\n\n          -  require randomization to intervention or control (could be best medical care or active\n             control or placebo or other type of control);\n\n          -  provide transportation costs for trial participants who need assistance in getting to\n             trial sites or use some RECRUIT reimbursement for this purpose.\n\n        The clinical site must\n\n          -  be a funded Clinical Site in the parent trial;\n\n          -  be located in an area where at least 20% of the population within 30 miles in the age\n             group under study in the parent trial are from diverse populations.\n\n        Exclusion Criteria:\n\n          -  site does not agree to be randomized;\n\n          -  investigator or coordinator is under 18 years of age.
The patient is not receiving therapy in a concurrent clinical study and the patient agrees not to participate in other interventional clinical studies during their participation in this trial while on study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.
Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study;
Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed
Participants cannot have been treated on a prior interventional, investigational study within 2 weeks of the first dose of study treatment
Participation in an interventional, investigational study within 2 weeks of the first dose of study treatment.
The patient is not receiving therapy in a concurrent clinical study and the patient agrees not to participate in other interventional clinical studies during their participation in this trial while on study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.
Concurrent enrollment in another interventional trial
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Concurrent enrollment in another study unless it is an observational (e.g. non-interventional) study.
Current participation in any other interventional clinical study (except survival follow up).
Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of study entry Note: Patients who are participating in non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation.
Participation in another interventional clinical trial unless prior approval has been received from the Chimerix Medical Monitor (or designee).
Plan to be included into another interventional investigational study.
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
Participation in another interventional study requiring investigational treatment intake within 2 weeks or at least 5 half-lives (whichever is longer) prior to first dose of S64315 (participation in non-interventional registries or epidemiological studies is allowed).
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study, is excluded
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
Concurrent enrollment in another clinical trial, unless in a follow-up period or it is an observational study
Concurrent enrollment in another clinical study, unless in a follow-up period or the study is an observational or non-interventional study
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nConcurrent enrollment in another clinical study, unless it is an observational non-interventional clinical study or the follow-up of an interventional study
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nConcurrent enrollment in another clinical study, unless it is an observational non-interventional clinical study or the follow up of an interventional study
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nConcurrent enrollment in another clinical study, unless it is an observational non-interventional clinical study or the follow-up of an interventional study; any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable; NOTE: Local treatment of isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy)
Concurrent participation in any interventional clinical trial.
201 Treatment within 30 days prior to enrollment with another investigational device or drug (interventional clinical study / studies). Other investigational procedures while participating in this study are excluded (observational studies are permitted).
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment; receipt of any investigational or approved anticancer therapy (chemotherapy, targeted therapy, biologic therapy, monoclonal antibodies, etc.) within 21 days or 5 half lives, whichever is shorter, prior to the first dose of MEDI0457; concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Concurrent enrollment in another clinical study, except for non-interventional, observational studies
Participation in another interventional clinical trial at the time of enrollment
Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
Participation in another interventional clinical trial within the past 30 days (participation in observational studies is permitted)
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study.
Participation in an interventional, investigational study within 2 weeks of the first dose of study treatment.
Prior treatment in any other interventional clinical trial within 4 weeks prior to Day 1 of the study.
Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study
Patients who have participated in other interventional (treatment-related) clinical trials within 30 days of enrollment are excluded
Treatment with any known therapeutic or experimental therapy within 4 weeks prior to enrollment, or currently participating in any other interventional clinical study
Enrollment in another interventional study.
Concurrent enrollment in another clinical study, unless in a follow-up period or it is an observational study
Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment, or currently participating in any other interventional clinical study for NHL or any other illness (except observational and registry trials)
Received investigational drug within 30 days prior to study dosing. Patients may participate in non-interventional or observational clinical studies, including the 10PLK13 PROCLAIM registry study.
Currently participating in any other interventional clinical study
The patient is not receiving therapy in a concurrent clinical study and the patient agrees not to participate in other interventional clinical studies during their participation in this trial while on study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment
Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment, or currently participating in any other interventional clinical study for NHL or any other illness (except observational, prevention, and/or registry trials)
Received treatment with an investigational agent within 4 weeks of study entry, or is actively participating in another interventional clinical study.
Concurrently enrolled in another clinical study, except for non-interventiona observational studies, or if in a follow up period from a previous study
Current or previous participation in the treatment phase of another interventional clinical study within 4 weeks prior to randomization. Patients may continue in the follow-up phase of another interventional clinical study, but may not have undergone any treatment on the other study within 4 weeks prior to randomization.
Concurrent enrollment on other clinical research studies that contain an interventional therapy is not permitted while subjects are receiving pasireotide or within 5 half lives of finishing pasireotide; however, subjects may concurrently enroll in non-interventional studies (e.g. biobanking, mobile health tracking)
Participation in an interventional, investigational non-immunotherapy study within 2 weeks of the first dose of study treatment.
Enrollment on an interventional investigational study
Subject has concurrent participation in any interventional studies within 14 days of first dose of study drug.
Treatment with any experimental therapy within 30 days prior to enrollment or current participation in any other interventional clinical study
Be interventional trials