Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation, excluding RANKL inhibitors and bisphosphonates); in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least 7 days prior to registration and any therapy-induced toxicity must have recovered to =< grade 1, except alopecia and =< grade 2 neuropathy which are allowed; any planned radiation therapy must be completed before enrollment onto S1609
Patients must not be planning treatment with other systemic anti-cancer agents (e.g., chemotherapy, hormonal therapy, immunotherapy) or other treatments not part of protocol-specified anti-cancer therapy including concurrent investigational agents of any type
Patients must not be planning to require any additional form of systemic anti-tumor therapy while on protocol treatment
Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis; first-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2, or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given; if given before study entry, it cannot have exceeded a duration of 12 months at the time of registration (Note: sequencing of ablative therapy [surgery or SBRT] relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician)
Persistence of clinically relevant therapy related toxicity from previous anti-cancer therapy
Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to Cycle 1 Day-2.
Participants who have had prior anti-EGF or anti-HER2 therapy or cancer-directed chemotherapy
3. Receipt of any investigational anti-cancer therapy within 4 weeks prior to first dose of TAB001;
Escalation Phase: Subjects may be enrolled with ? 2 lines of prior systemic anti-cancer therapy (but no immunotherapy). Subjects who have had no prior systemic anti-cancer therapy (i.e. first-line therapy) or declined first-line treatment are permitted in the Escalation Phase.
For Cohort C only: any prior anti-cancer therapy for advanced melanoma
Patients with prior hepatitis B vaccine are permitted (defined as HBsAg-, Anti-HBs+, Anti-HBc-).
Recent systemic anti-cancer therapy
No prior other anti-cancer therapy, including ACT, for 28 days prior to study administration of atezolizumab
Prior cancer therapy or anti-cancer vaccine within 4 weeks of initial study treatment.
Concurrent or planned systemic chemotherapy, radiotherapy, new hormonal or anti- HER2 directed therapy directed at management of breast cancer (existing anti-HER2 therapy can be continued as recently recommended in the National Consensus Guidelines)
At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
Last anti-cancer treatment within 2 weeks prior to study entry
Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start
Ongoing or planned systemic anti-cancer therapy or radiation therapy
Participant has received anti-cancer traditional medicine or anti-cancer herbal remedies within 14 days prior to ABBV-744 dosing. Saw palmetto is considered anti-cancer herbal remedy. Participant with CRPC who has received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day 1. Participant with AML has received anti-cancer therapy within a period of 14 days or 5 half-lives (whichever is longer; except for immunotherapy where a period of 21 days will be acceptable) prior to Study Day 1. Except for hydroxyurea which will be allowed during screening and treatment for controlling leukocytosis for AML subjects.
Prior standard or investigational anti-cancer therapy, as specified below:
Concurrent administration of any other anti-cancer therapy (except male participants with prostate cancer receiving androgen blockade: Bisphosphonates and denosumab are allowed; Most recent anti-cancer therapy </=28 days and have not recovered from the side effects, excluding alopecia; Radiaiton therapy within </=14 days
Any prior anti-cancer chemotherapy, biologic or investigational therapy for PDAC.
At least 3 weeks must have passed since any prior anti-tumor therapies including chemotherapy, radiation therapy or any other anti-cancer treatments
Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible
Prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug
Concurrent use of another anti-cancer drug including an investigational anti-cancer agent
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study enrollment
Patient shouldn’t have received any anti-cancer therapy for glioblastoma in past
Patients requiring anti-coagulant therapy
Has had any systemic anti-cancer therapy (includes anti-VEGF therapy or any systemic investigational anti-cancer agent)
Naive to prior systemic anti-cancer therapy for melanoma
Monoclonal antibody based anti-cancer therapy within 28 days prior to study entry or small-molecule based anti-cancer therapy (targeted therapy or chemotherapy) within 14 days prior to study entry.
Subjects must not have received any prior standard or investigational anti-tumor therapy other than surgery and must not intend to receive any standard or investigational anti-tumor therapy other than the study regimen
Prior use of any standard or investigational anti-tumor therapy other than surgery
Anticancer chemotherapy during the study or within 4 weeks of study enrollment; subjects must have recovered from the toxic effects of the previous anti-cancer chemotherapy (with the exception of alopecia); anti-cancer therapy is defined as any\r\nagent or combination of agents with clinically proven anti-tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints
Concurrent administration of other anti-cancer therapy within 14 days of starting protocol therapy and during the course of this study
Patients may not be receiving the concomitant administration of any systemic therapy, biologic therapy, or other agents with anti-tumor activity against prostate cancer while the patients are on study.
Current or prior anti-cancer treatment prior to the first dose of pembrolizumab as defined below:\r\n* Chemotherapy, targeted small molecule therapy, or other anti-cancer treatment not otherwise specified below within 2 weeks\r\n* Radiation therapy within 2 weeks\r\n* Anti-cancer monoclonal antibody (mAb) treatment within 4 weeks\r\n* Use of an investigational agent (e.g., biologic, drug, or other) within 4 weeks\r\n* Allogeneic stem cell transplant within 100 days\r\n* Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent at any time
Patients may not be receiving any other anti-cancer therapy.
Patients, who have previously received in vivo anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging, are eligible unless they have had an anaphylactic reaction attributed to anti-GD2 therapy
Concomitant use of any anti-cancer therapy or radiation therapy
FOR ALL PHASES (Ib AND II): Concurrent therapy with any other non-protocol anti-cancer therapy
Has had a prior systemic anti-cancer treatment within the last 8 weeks
Patients with a diagnosis of CD22-positive acute lymphoblastic leukemia (ALL) based on local immunophenotyping and histopathology who have:\r\n* Refractory disease, defined as disease progression or no response while receiving their most recent prior anti-cancer therapy,\r\n* Relapsed disease, defined as response to their most recent prior anti-cancer therapy with subsequent relapse
Immunosuppressive therapies within 4 weeks of leukapheresis and JCAR017 administration (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolyate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti IL6, or anti-IL6R)
One prior anti-cancer therapy that did not work
More than one line of anti-cancer therapy or no treatment at all
Any prior systemic anti-cancer immunotherapy treatment
Prior anti-tumor therapy within 3 weeks of cycle 1 day 1 (anti-tumor therapy defined as, but is not limited to, anti-cancer agents (cytotoxic chemotherapy, immunotherapy, and biologic therapy), radiotherapy, and investigational agents), the “wash-out period”
Evidence of active infection that requires anti-bacterial, anti-viral, or anti-fungal therapy =< 7 days prior to initiation of study drug therapy
Concurrent treatment with other anti-cancer therapy is not permitted
Receipt of any anti-cancer therapy within 14 days of starting BP1001, with the exception of hydroxyurea or anagrelide, or TKI (within 2 days)
PART 2 GROUP 1 EXCLUSION CRITERIA: Other concomitant therapies\r\n* Corticosteroids that were initiated for anti-tumor effect within seven days prior to initiation of protocol therapy\r\n* Investigational drugs\r\n* Anti-cancer agents\r\n* Hematologic growth factors\r\n* Radiation therapy
PART 2 GROUP 2A EXCLUSION CRITERIA: Other concomitant therapies\r\n* Corticosteroids that were initiated for anti-tumor effect within seven days prior to initiation of protocol therapy\r\n* Investigational drugs\r\n* Anti-cancer agents\r\n* Hematologic growth factors\r\n* Radiation therapy
PART 2 GROUP 3 EXCLUSION CRITERIA: Other concomitant therapies\r\n* Corticosteroids that were initiated for anti-tumor effect within seven days prior to initiation of protocol therapy\r\n* Investigational drugs\r\n* Anti-cancer agents\r\n* Hematologic growth factors\r\n* Radiation therapy
Is currently receiving active treatment with anti-cancer systemic chemotherapy, investigational agent, or biological therapy
Subject has received any of the following:\r\n* Chemotherapy, biological therapy, or surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to on-study date\r\n* Radiation therapy, within 10 weeks prior to entering the study or those who have not recovered from adverse events due to radiation administered more than 10 weeks prior to on-study date\r\n* Prior therapy with bevacizumab\r\n* Prior therapy with an anti-programed cell death 1 (PD-1), anti-programed cell death 1-ligand (PD-L)1, anti-PD-L2, anti-cluster of differentiation (CD)137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody\r\n* Prior treatment with an HDAC inhibitor, with the exception of prior or current treatment with valproate\r\n* Any investigational agents or have had any investigational agent within the 30 days prior to on-study date\r\n* A live vaccine within 30 days prior to on-study date\r\n* Previous treatment with carmustine wafer except when administered as first line treatment and at least 6 months prior to on-study date
Excluded therapies and medications for cancer\r\n* Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study enrollment; subjects must have recovered from the toxic effects of the previous anti-cancer chemotherapy or immunotherapy (with the exception of alopecia); anti-cancer therapy is defined as any agent or combination of agents with clinically proven anti-tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints; however, subjects with prostate cancer who are receiving depot luteinizing hormone-releasing hormone (LHRH) agonist therapy may continue on this treatment\r\n* Hormonal therapy during the study or within 2 weeks of first study enrollment\r\n* Radiotherapy to target lesions during study or within 4 weeks of first study treatment\r\n* An irradiated lesion is considered evaluable only if it has shown enlargement since the completion of last radiation\r\n* Bone marrow transplant or stem cell rescue\r\n* Bisphosphonate therapy during the first 2 cycles of treatment\r\n* Granulocyte colony stimulating factor (G-CSF) and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the principal investigator; however they may not be substituted for a required dose reduction; erythropoietins are not permitted\r\n* Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment
Prior anti-estrogen therapy within the last 5 years
Have received NO anti-cancer therapy within 28 days prior to receiving study drug
Receiving concurrent anti-cancer treatment (excluding radiation therapy), either approved or investigational
Has been treated with anti-cancer therapy or thoracic radiation therapy within 14 days
Is receiving concurrent anti-cancer therapy for metastatic disease
Any anti-cancer therapy within the past 21 days of the first day of treatment
Concurrent treatment with other investigational drugs or anti-cancer therapy.
Concomitant use of any anti-cancer therapy or radiation therapy
For purposes of this protocol, anti-tumor treatment may be defined as, but is not limited to, anti-cancer agents (cytotoxic chemotherapy, immunotherapy, biologic therapy), radiotherapy, and investigational agents; an investigational agent is any drug or therapy not currently approved for use in humans\r\n* Anti-cancer agents: anti-cancer agents are not permitted within 21 days prior to start of POPI; there are no limitations on the type or number of prior regimens; hormonal therapy and trastuzumab are permitted during POPI\r\n* Radiation: prior treatment with breast irradiation is not allowed \r\n* Surgery: incident breast biopsies only permitted prior to POPI to confirm residual disease after NAC
Other concomitant anti-cancer therapy except corticosteroids
Other anti-cancer or investigational therapy while patients are on study therapy
Received the last anti-cancer therapy at least 28 days ago
Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)
Treatment with other investigational drugs or anti-cancer therapy within 28 days prior to enrolment.
Any ongoing toxicity from prior anti-cancer treatment that, in the judgement of the investigator, may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 (NCI CTCAE version 4) or baseline prior to enrollment. Eligible patients must not require more than 10 mg/day prednisone (or equivalent dose).
Received prior systemic anti-cancer therapy for NSCLC
Concurrent anti-cancer therapy
Has received systemic anti-cancer therapy within the 3 weeks prior to starting the trial.
Have received last dose of first-line systemic anti-cancer therapy or date of most recent local regional therapy >28 days prior to day 1
Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.
Patient is concurrently using other anti-cancer therapy. All anti-cancer therapy must be discontinued prior to day one of study treatment.
ARM A: Systemic anti-cancer therapy =< 4 weeks prior to registration
ARM B: Systemic anti-cancer therapy =< 4 weeks prior to registration
Concomitant therapy with any anti-cancer agents, other investigational anti-cancer therapies, or immunosuppressive agents including but not limited to methotrexate, chloroquine, azathioprine, etc. within six months of study participation
Any anti-cancer therapy or investigational agents =< 4 weeks prior to registration
Concomitant therapy with any anti-cancer agents, other investigational anti-cancer therapies, or immunosuppressive agents; chronic use of systemic corticosteroids
Use of other anti-cancer therapies within five half-lives from the previous dose of the prior anti-cancer therapy preceding enrollment and during the study
Prior investigational anti-cancer therapy within 4 weeks prior to day 1
GVHD therapies: Any systemic drug used for GVHD must be stopped > 4 weeks prior to CTL019 infusion to confirm that GVHD recurrence is not observed (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolate, rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD20 (rituximab), anti-tumor necrosis factor [anti-TNF], anti-interleukin 6 [anti-IL6] or anti-interleukin 6 receptor [anti-IL6R], systemic steroids)
Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
Concurrent administration of any other anti-cancer therapy within 14 days of starting protocol therapy and during the course of this study (bisphosphonates and RANK ligand inhibitors are allowed)
GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CTL019 infusion (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolyate, rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD20 (rituximab), anti-TNF, anti-IL6 or anti-IL6R)
Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted
Patients must not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); these medications must have been started 1 month prior to enrollment on this study; in addition, men receiving treatment for prostate cancer will be maintained at castrate levels of testosterone by continuation of luteinizing-releasing hormone agonists
No ongoing toxicity from prior anti-cancer treatment that may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 or baseline before administration of the study treatment.
No previous anti-cancer treatment
Any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy (including monoclonal antibodies), or experimental anti-cancer therapy) within 28 days prior to beginning study therapy. Note: Ongoing castrating therapy with a GnRH agonist or antagonist is mandatory to assure a castrate level of serum testosterone <50 ng/dL, except in patients who have undergone an orchiectomy. Bisphosphonates or denosumab continuation is permissible (i.e., no change for 30 days prior to Cycle 1 Day 1). Patients who receive a dose of EC1169 under another Endocyte protocol do not need a washout period for EC1169
Any anti-cancer therapy within 3 weeks of study drug
No prior systemic anti-cancer therapy for advanced ER+ disease
Evidence of active infection that requires anti-bacterial, anti-viral, or anti-fungal therapy =< 7 days prior to initiation of study drug therapy
No prior systemic anti-cancer therapy for advanced ER+ disease.
However, subjects who are HER-2 positive and responsive to anti-HER-2 therapy (e.g. Herceptin), are encouraged to remain on anti-HER-2 therapy and not enroll in this trial.
Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
Concomitant use of any anti-cancer therapy or radiation therapy, or any other investigational agent
Prior anti-HER2 targeting therapy
Received systemic anti-cancer therapy within 30 days of Week 0, Day 11 of study treatment.
Recent cancer-directed therapies: Radiotherapy (RT) within 4 weeks, chemotherapy or other systemic anti-cancer therapy within 4 weeks, or prior anti-angiogenic treatment (e.g., bevacizumab) within 6 weeks prior to starting treatment
Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic or immunotherapy agents that can present with major delayed toxicity (eg, anti-CTLA-4), 4 weeks is indicated as washout period
More than 1 previous systemic anti-cancer therapy line
Patients receiving anti-cancer therapy within 21 days before MSC treatment
Patients who are receiving any other anti-cancer or investigational drug therapy are excluded
Alternative anti-cancer treatment
Anti-cancer therapy =< 14 days prior to randomization
Patients who are currently taking any anti-cancer directed therapy; steroids are not considered anti-cancer therapy
Participation in an investigational anti-cancer study within 3 weeks prior to initiation of therapy
For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable)
No prior systemic anti-cancer therapy for advanced disease.
Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer Note:
Patients who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames:
Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
Other concomitant anti-cancer therapy agents excepts steroids
Uncontrolled cancer requiring the institution of new anti-cancer therapy during the study period
Patients who have received systemic anti-cancer therapy such as chemotherapy, immunotherapy and/or biologic therapy =< 4 weeks prior to study entry; concurrent anti-cancer therapy (chemotherapy, immunotherapy, biologic therapy) other than the ones specified in the protocol is not permitted during study participation; patients must have discontinued the above cancer therapies for 4 weeks prior to the first dose of study medication, as well as recovered from toxicity (to =< than grade 1, except for alopecia) induced by previous treatments; any investigational drugs should be discontinued 4 weeks prior to the first dose of study medication
Any systemic anti-cancer treatment out of allowed timelines
Other concomitant anti-cancer therapy agents except steroids
Prior anti-tumor therapy within 2 weeks
Ongoing or planned systemic anti-cancer therapy or radiation therapy
Any concurrent anti-cancer therapy, excluding hormonal therapy for prostate or breast cancer
Specific anti-cancer therapy within 3 weeks of study start
Prior therapy with anti-angiogenic agents is permitted
Has received systemic anti-cancer therapy within the 14 days prior to randomization
Treatment with any immunomodulatory medication within 4 weeks of initiation of study therapy, except for anti-tumor therapy (e.g., anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4])
Anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or cancer immunotherapy within 4 weeks prior to the first dose of the investigational drug.
Toxic effects of previous anti-cancer chemotherapy, experimental cancer therapy, or cancer immunotherapy have not normalized.
Use of any anti-cancer drug therapy within 14 days prior to Baseline (within 28 days for monoclonal antibodies [eg anti-CD38]).
Concurrent therapy with any other non-protocol anti-cancer therapy
Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy
Prior anti-androgens are permitted but not required (2 week washout from anti-androgens)
Treatment with any approved anti-cancer therapy within 3 weeks prior to the first dose of study treatment
Has received other anti-cancer therapy within the following specified intervals prior to Day 1:
Concurrent treatment with other anti-cancer therapy
Anti-cancer therapy within 28 days prior to the first dose of study-drug treatment in Cycle 1
Prior anti-estrogen therapy.
Use of any approved anti-cancer therapy within 3 weeks prior to treatment
Subjects enrolling in the study who have non-breast, non-gastric, non-gastroesophageal junction cancers do not require any prior treatment with anti-HER2 therapy if there is no FDA-approved anti-HER2 agent for their specific cancer type, but they must have refractory or relapsed/progressive disease during or following their last prior anti-cancer therapy.
Anti-tumor therapy within 14 days of study day 1
Concurrent anti-cancer treatment, except anti-hormonal therapy for subjects with hormone receptor positive breast cancer
Therapeutic anti-coagulative or long term anti-platelet treatment.
Anti-tumor therapy within 21 days of study Day 1
Patients receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); these medications must have been started >= month prior to enrollment on this study; patients may be on low molecular weight heparin or direct factor Xa inhibitors
For Part 1, subjects may have had any number of prior systemic anti-cancer treatments, but may not have received more than 2 schedules of myeloablative chemotherapy. For Parts 2 and 3, more than two prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma are not permitted. Prior systemic treatment in the adjuvant setting is allowed. (Note: Ipilimumab treatment must end at least 8 weeks prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3.)
Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without delayed toxicity within treatment specific timeframe.
Concurrent therapy with any other non-protocol anti-cancer therapy
For Arms A and C: Treatment with any FGFR inhibitor. For Arm B: Treatment with any anti-cancer therapy (for biological anti-cancer therapies see criteria below) during the preceding 4 weeks or within 4 half-lives of the therapy, whichever is longer.
Prior anti-cancer therapy
Completion of last anti-cancer therapy must be at least 28 days prior to study drug administration.
Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
Anti-tumor therapy
Patients on concurrent anti-cancer therapy other than that allowed in the study
Anti-platelet drugs within 4 weeks prior to the first dose of study drug. Anti-platelet drugs are defined as any agent or combination of agents with clinically proven anti-thrombotic activity administered by any route with the purpose of affecting blood clotting ability of the subject.
Evidence of active infection, requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy < 7 days prior to administration of study medication
Prior anti-cancer treatment permitted (with specific criteria)
No previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in Phase Ib). Previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if greater than 6 weeks of first day of study-defined treatment;
Previously received E7050 anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in Phase Ib only);
Less than (<) 4 weeks since the last anti-tumor therapy prior to Day 1 of study treatment
Concurrent therapy with any other non-protocol anti-cancer therapy
Patients on concurrent anti cancer therapy other than that allowed in the study.
No prior anti-cancer treatment
No prior treatment with systemic anti-cancer therapy for SCCHN unless protocol-defined conditions are met.
Subjects on anti-cancer medication whether biologic or pharmaceutical
Completion of last anti-myeloma therapy (if any) must occur at least 14 days before conditioning
Subjects on anti-cancer medication whether biologic or pharmaceutical
Anti-cancer therapy within 28 days prior to starting on therapy
Prior anti-cancer therapy within 28 days before the first dose of study drug
Received a new anti-cancer agent within 4 weeks prior to registration
No other investigational or standard anti-tumor therapy allowed
Must have received systemic therapy for their breast cancer (anti-estrogen and/or chemotherapy)\r\n* Chemotherapy must be complete prior to entry\r\n* Anti-estrogen therapy may be ongoing
Concurrent anti-cancer therapy
Prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug
Patients must not be receiving anti-myeloma therapy (including maintenance therapy)
Patients deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations
Patients must not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); in addition, men receiving treatment for prostate cancer will be maintained at castrate levels of testosterone by continuation of luteinizing-releasing hormone agonists
Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
Patients must be anti-angiogenic therapy naive
Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
Persistent acute toxicities from prior anti-cancer therapy.
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to randomization
Patients must not have clinical signs or symptoms of active tuberculosis infection
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 14 days prior to randomization
Signs or symptoms of infection within 2 weeks before initiation of study treatment
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to first day of study
GENERAL: Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1.
Signs or symptoms of clinically relevant infection within 2 weeks prior to Day 1 of Cycle 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to start of study treatment.
Signs or symptoms of infection within 2 weeks prior to first day of study treatment
Signs or symptoms of infection within 2 weeks prior to the first study treatment
Signs or symptoms of infection within 2 weeks prior to study treatment
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of active infection within 2 weeks prior to cycle 1 day 1
Signs or symptoms of infection =< 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Biliary obstructive symptoms or signs
Symptoms/signs suggestive of influenza like illness (ILI)
Signs or symptoms of infection within 2 weeks prior to Day 1 of Cycle 1
Patients who have signs or symptoms of infection within 2 weeks before initiation of study treatment
Signs or symptoms of infection as determined by the treating team within 2 weeks prior to cycle 1, day 1.
Signs or symptoms of infection =< 2 weeks prior to registration
Signs or symptoms of infection within 2 weeks prior to week 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Cohort A (asymptomatic): Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy within 10 days prior to first treatment. Cohort B (symptomatic): Subjects with neurologic signs and symptoms related to metastatic brain lesions are eligible per Amendment 02. Subjects with neurologic signs and symptoms may be treated with a total daily dose of no more than 4 mg of dexamethasone that is stable or tapering for 10 days prior to first treatment. Subjects with neurologic signs and symptoms who are not being treated with steroids are eligible for Cohort B and should have no experience of seizure within 10 days prior to first treatment.
Signs or symptoms of infection within 2 weeks prior to first dosing.
Severe infections within 4 weeks or signs or symptoms of infection within 2 weeks prior to Cycle 1
Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs:
Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
Signs/symptoms of infection, or use of antibiotics within 2 weeks of study drug
Any signs and/or symptoms of brain metastases must be stable for ? 4 weeks
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1; abnormal urinalysis does not constitute signs/symptoms of infection unless urine culture obtained at screening grows >= 100,000 colonies of bacteria; patients with an ileal conduit and a urinalysis and/or culture that are abnormal are eligible unless they have peripheral blood white blood cell (WBC) > ULN, fever, or other symptoms suggestive of a urinary tract infection
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of severe infection (sepsis) within 2 weeks prior to treatment start
Symptoms or signs of active brain metastases;
Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1
Patients with any signs/symptoms of interstitial pneumonia
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of progressive or uncontrolled liver disease
Signs or symptoms of infection within 2 weeks prior to the first dose of study treatment
Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
Active B symptoms
Subjects who exhibit signs of an infection at screening will be rescheduled when symptoms have resolved
Signs or symptoms of significant infection within 2 weeks prior to Day 1
No signs or symptoms of BRONJ
Received chemotherapy or radiotherapy within 3 weeks prior to randomization or those who have not recovered to =< grade 1 adverse events (other than alopecia) due to agents administered more than 3 weeks earlier; herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization; for patients who received prior immunotherapy (eg anti-CTLA-4), at least five drug half-lives must have passed before the patient may enroll on this study; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Palliative radiotherapy for bone metastases >= 2 weeks prior to randomization
Patients who have not recovered from adverse events to < grade 1 (other than alopecia) due to agents administered more than 3 weeks earlier; however, the following therapies are allowed:\r\n* Hormone replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier are excluded; however, the following therapies are allowed: \r\n* Hormone-replacement therapy or oral contraception\r\n* Herbal therapy > 7 days prior to randomization (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization)\r\n* Palliative radiotherapy for bone metastases > 14 days prior to randomization
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 2 weeks earlier; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
Anticancer therapy, including but not limited to chemotherapy, hormonal therapy, or radiotherapy, within 4 weeks prior to start of study treatment; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives.\r\n* Herbal therapy > 1 week prior to start of study treatment (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to start of study treatment).\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to start of study treatment.
Any approved anticancer therapy, including chemotherapy and hormonal therapy within 3 weeks prior to initiation of study treatment; however, the following are allowed: a) Hormone-replacement therapy or oral contraceptives b) Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
Any approved anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, =< 3 weeks prior to first dose of study drug; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anti-cancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
Patients who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier (i.e., have residual toxicities > grade 1); however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy ? 1 week before initiation of study treatment (herbal therapy intended as anticancer therapy must be discontinued at least 1 week before initiation of study treatment)\r\n* Palliative radiotherapy for bone metastases > 2 weeks before initiation of study treatment
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed: Hormone-replacement therapy; palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1.
Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 2 weeks prior to initiation of study treatment, with the following exceptions:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week before week 1, day 1 (herbal therapy intended as anti-cancer therapy must be discontinued at least 1 week before week 1, day 1)
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1; herbal therapy intended as anticancer therapy must also be discontinued at least 1 week prior to cycle 1, day 1\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the following exceptions: hormone-replacement therapy or oral contraceptives; tyrosine kinase inhibitors (TKIs) that have been discontinued > 7 days prior to cycle 1, day 1; screening scans must be obtained after discontinuation of prior TKIs
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed: i. Hormone-replacement therapy or oral contraceptives ii. Herbal therapy > 1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1, Day 1)
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives \r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed: Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy ? 3 weeks prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Patients who have had chemotherapy within 3 weeks or radiotherapy or targeted therapy 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier; however, the following therapies are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)\r\n* Palliative radiotherapy for bone metastases > 2 weeks prior to cycle 1, day 1
Herbal therapy (including herbal therapy intended as anticancer therapy) < 1 week prior to cycle 1, day 1
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 5 years prior to initiation of study treatment; however, the following are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* Herbal therapy > 1 week prior to cycle 1, day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to cycle 1, day 1)
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed:\r\n* Hormone-replacement therapy or oral contraceptives\r\n* TKIs approved for treatment of NSCLC discontinued > 7 days prior to cycle 1, day 1; the baseline scan must be obtained after discontinuation of prior TKIs
Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
Patients may have received one and only one cycle of chemotherapy prior to enrolling on Cancer and Leukemia Group B (CALGB) 30610, which must have included carboplatin or cisplatin and etoposide; if a patient has had one cycle of cisplatin (or carboplatin)/etoposide prior to registration, the patient must have had all of the prior to registration tests prior to starting their first cycle of chemotherapy; additionally, these patients also must have met all of the eligibility criteria prior to receiving the first cycle of chemotherapy; registration to CALGB 30610 must take place within 7-21 days after the start of the non-protocol therapy; failing to do all of the above will make the patient NOT eligible for CALGB 30610
Patients must not have unequivocal disease progression (by RECIST v1.1) during the first cycle; patients must have disease assessed using the same method as baseline within +/- 5 days of the day 56 scheduled assessment (between days 51-55 of cycle 1, or days 1-5 of cycle 2); all disease must be assessed and documented on the follow-up tumor assessment form (RECIST 1.1)
Patients must be registered to step 2: randomization within +/- 5 days of starting cycle 2; patients MUST NOT be registered prior to the day 56 disease assessment
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Phase 1 ONLY: Subject has had any prior anti-cancer therapy other than: Hormonal, non-myelosuppressive, biologic, targeted, or immune therapy (must be completed ? 4 weeks prior to Cycle 1 Day -2). One line of cytotoxic chemotherapy (must be completed ? 4 weeks prior to Cycle 1 Day -2). Adjuvant/neoadjuvant radiotherapy (must be completed ? 12 months prior to Cycle 1 Day -2, with field not involving > 10% of bone marrow reserve).
Phase 2 ONLY: Subject has had any prior chemotherapy, radiotherapy, investigational anti-cancer agents or biologic therapy for the disease under study. Single non-target lesion irradiation with intent of symptom palliation is allowed if ? 4 weeks prior Cycle 1 Day -2.
Previous treatment with radiotherapy or immunotherapeutic agents in the 4 weeks prior to study drug administration (Cycle 1 Day 1)
Use of immunosuppressant medications in the 2 weeks prior to study drug administration (Cycle 1 Day 1)
Prior therapy with immune-activating agents within less than 1 cycle length prior to first day of study treatment (e.g. 3 weeks for ipilimumab or pembrolizumab; 2 weeks for nivolumab) (for treatment phase)
Any other systemic or regional anticancer therapy (cytotoxic chemotherapy, embolization) within 3 weeks or 1 cycle length, whichever is shorter, prior to first day of study treatment (for treatment phase)
Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor (CAR) T cells directed against B cells within 8 weeks of Cycle 1 Day 1
Receipt of investigational treatment within 3 weeks of scheduled Cycle 1 Day 1 (C1D1) dosing.
Treatment with investigational therapy within 14 days prior to Cycle 1, Day 1
Treatment with any anti-cancer agent 14 days prior to Cycle, Day 1 other than aPD-1 based therapy
The following laboratory results must be met during screening and also immediately before study drug administration on Cycle 1 Day 1:
Prior standard or investigational anti-cancer therapy as specified: Radioimmunoconjugate within 12 weeks prior to Day 1 of Cycle 1; Monoclonal antibody or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1; Radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1).
Participation in any interventional study within 4 weeks of Cycle 1 Day 1 or 5 half-lives of the investigational agent(s) used in the interventional study prior to Cycle 1 Day 1 (whichever is longer).
Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Controlled brain metastases that require continuous high dose corticosteroid use within 4 weeks of Cycle 1 Day 1.
Subject must have adequate organ function as defined below. The following parameters must be evaluated within 28 days prior to Cycle 0 Day 1 (monotherapy run-in period):
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Average transfusion requirement of ? 2 units per 28 days of packed RBCs confirmed for a minimum of 112 days immediately preceding Cycle 1 Day 1.
No consecutive 56 days that was RBC transfusion-free during the 112 days immediately preceding Cycle 1 Day 1.
Use of an ESA within the 4 weeks prior to Cycle 1 Day 1.
Have no symptoms of cranial hypertension or convulsions within 14 days before Cycle 1 Day 1 (anti-epileptic drugs and corticoids are allowed to control any preexisting symptoms)
Receipt of anti-cancer therapy 14 days prior to Cycle 1 Day 1
Platelet count >= 100 X 10^9/L within 14 days of starting cycle 1 day 1 treatment
Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
Has persistent phosphate level greater than upper limit of normal (ULN) during screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical management
Research MRI sequences performed at Massachusetts General Hospital Charlestown Navy Yard must be completed =< 7 days of cycle 1 day 1
Progressive disease on bendamustine within 6 months of cycle 1, day 1
Treatment with systemic steroids for > 4 weeks prior to cycle 1 day 1 of study therapy; prior radiation therapy, with the exception of an abbreviated course (not more than 3 days) if used for superior vena cava (SVC) syndrome
Chemotherapy or targeted therapy within 14 days prior to cycle 1 day 1 of protocol therapy
Current use or history of receiving a non-approved, investigational treatment within 14 days prior to cycle 1 day 1 of protocol therapy
Previous radiotherapy within 7 days of Cycle 1 Day 1.
Treatment with any other investigational agent within 3 weeks prior to cycle 1, day 1
Radio-immunoconjugate within 12 weeks prior to Day 1 of Cycle 1.
Prior treatment of PTCL with systemic anti-lymphoma therapies, investigational agents, radiation; exception: may have received 1 cycle of CHOP-like therapy (e.g. CHOP, CHOEP, EPOCH); these participants must initiate day 1 cycle 1 of CHEP-BV no less than 19 days from prior CHOP-like therapy
Episode of significant cardiovascular/cerebrovascular acute disease within 6 months prior to Cycle 1 Day 1
Malignancies other than UC within 5 years prior to Cycle 1, Day 1
Failed prior alloSCT within the past 6 months from Cycle 1 Day 1
Prior treatment with bicalutamide (Casodex®) or nilutamide (Nilandron®) within 6 weeks of Cycle 1, Day 1
Administration of an investigational therapeutic agent within 28 days of Cycle 1, Day 1
At least 1 week since the last systemic therapy regimen prior to Cycle 1 Day 1. Subjects on a stable dose of hydroxyurea for at least 2 weeks prior to Cycle 1 Day 1 may continue on hydroxyurea until Cycle 1 Day 7. Subjects must have recovered to NCI CTCAE v. 4.03 < Grade 2 from all acute toxicities (excluding Grade 2 toxicities that are not considered a safety risk by the Sponsor and Investigator) or toxicity must be deemed irreversible by the Investigator.
Ongoing treatment with an anticancer agent for CMML not contemplated in this protocol. Subjects on a stable dose of hydroxyurea for at least 2 weeks prior to Cycle 1 Day 1 may continue on hydroxyurea until Cycle 1 Day 7.
Cytotoxic therapy within 21 days prior to cycle 1 day (D) 1
The tumor site selected for injection cannot have been irradiated within 8 weeks of Cycle 1 Day 1 (C1D1)
Any systemic anticancer therapy within 3 weeks prior to Cycle 1, Day 1
Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
Patients who have received:\r\n* Radiation or chemotherapy =< 4 weeks\r\n* Mitomycin C, nitrosureas, or radio-immunotherapy =< 6 weeks, or\r\n* Immunotherapy or targeted therapy (such as kinase inhibitors) =< 2 weeks prior to cycle 1 day 1; patients who are on ibrutinib at study entry are not required to discontinue ibrutinib for any period of time\r\n* Palliative steroids for disease related symptoms are allowed as long as dose is tapered down to an equivalent of =< 10 mg of oral prednisone daily on cycle 1 day 1
Chemotherapy within 2 weeks of first dose of sEPHB4-HSA (minimum of 6 weeks for nitrosoureas and 8 weeks for bone marrow transplantation) with the following exceptions:\r\n* Hydroxyurea allowed prior to, and up to day +5 of cycle 0 of treatment (max 100 mg/kg/day)\r\n* Corticosteroids allowed until day -3 (max dexamethasone 20mg/day)\r\n* Maintenance chemotherapy for ALL allowed one week prior to start of treatment (e.g., POMP)
Adequate organ function with the following laboratory results during screening (within 21 days) and immediately before study drug administration on Cycle 1 Day 1:
Be willing to provide peripheral blood samples at screening and day 1 of cycle 2 and cycle 3 for correlative studies
Obtained within 21 days prior to cycle 1, day 1: serum bilirubin =< 1.5 x ULN
Within 28 days of cycle 1 day 1: Platelets >= 75,000/mcL
Patients who have received any other investigational agents within the past 28 days prior to cycle 1 day 1
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
Patients who have not recovered from side effects of prior systemic therapy prior to cycle 1 day 1
Receipt of anti-cancer therapy prior to Cycle 1 Day 1: no chemotherapy, radiation therapy, small molecule tyrosine kinase inhibitor (TKI), or hormonal therapy for the treatment of cancer within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1. No immune therapy or other biologic therapy (other monoclonal antibodies or antibody-drug conjugates [ADCs]) for the treatment of cancer within 28 days of Cycle 1 Day 1.
Prior systemic treatment with an azole drug within four weeks of cycle 1 day 1.
Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiotherapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to day 1 of cycle 1. Patients are permitted to be on dabrafenib and trametinib at start of therapy without wash-out period prior to day 1 of cycle 1. Dosing will change to protocol determined dose levels on day 1 of cycle 1.
Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic, untreated, not stable for >= 4 weeks prior to day 1 of cycle 1 (must be documented by imaging), or requiring corticosteroids to manage metastasis-related symptoms. Subjects who have been off of corticosteroids for at least 2 weeks prior to day 1 of cycle 1 or are on a stable dose of =< 10 mg per day of a prednisone equivalent for > 1 month prior to day 1 of cycle 1 can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks prior to day 1 of cycle 1.
Patients whose disease is refractory (defined as evidence of disease progression while on drug or within 3 months of its discontinuation) to more than 2 lines of chemotherapy given for CRPC. Any number of chemotherapies to which the patient’s disease is not refractory are allowed, as long as time on treatment did not exceed 6 months (counted from day 1 of cycle 1 to day 1 of the last cycle of treatment).
Be taking prednisone at a dose of =< 10 mg/day, 7 days prior to starting treatment (cycle 1 day 1[(C1D1])
Any other on-going chemotherapeutic, biologic, radiopharmaceutical, or investigational agent currently or within 28 days of cycle 1 day 1
Lymphoma that is not amenable for mandatory pre- and cycle 2 day 15 (C2D15) post-treatment biopsy
Adequate haematological and end-organ function, as per the local institutions reference ranges, within 72 hrs prior to day 1 of cycle 1 of treatment defined by the following:
Ability and availability to complete all prescribed biopsies (prior to the first evofosfamide dose and between day 15 of Cycle 2 and day 8 of Cycle 3)
Fewer than 28 days before Cycle 1 Day 1 since any prior chemotherapy (less than 42 days in the case of mitomycin or a nitrosourea)
Fewer than 28 days before Cycle 1 Day 1 since administration of hormonal or biological anti-neoplastic agents
Participation in another investigational drug trial concurrently or within 30 days of Cycle 1 Day 1, or a vaccine trial within 90 days of Cycle 1 Day 1
Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
Only participants whose lymphoma is untreated are allowed for the dose-finding portion; for the dose expansion cohort both untreated and participants who have received a maximum of one cycle of combination chemotherapy, including rituximab-containing regimens R-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone (CHOP) and R-EPOCH, prior are eligible; the start of previous chemotherapy cycle must occur at least 21 days prior and 28 days maximum to beginning treatment under this protocol, and such cycle will count towards the maximum of 6 cycles under this study (i.e. cycle off study will count as cycle 1)
Prior systemic anti-myeloma therapy within 14 days of Cycle 1 Day 1
Immunosuppressive therapy within 6 weeks of Cycle 1 Day 1
Daily corticosteroid requirement within 2 weeks of Cycle 1 Day 1
The following patients are allowed:\r\n* Patients may have been treated for AML or antecedent hematologic disorder with myeloid growth factors, recombinant erythropoietin, thalidomide, lenalidomide, 5-azacitidine or decitabine\r\n* Any prior chemo therapy must have been completed >= 2 weeks prior to day 1 of study treatment and the participant must have recovered to eligibility levels from prior toxicity\r\n* There is no limit for prior chemo regimens\r\n* Patients may have received hematopoietic stem cell transplantation for AML or other diseases\r\n* Hydroxyurea is allowed prior to day 1 of study treatment for count control and during cycle 1; the use of hydroxyurea is not allowed beyond completion of cycle 1
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Neutrophil count >= 1.5 x 10^9/l at cycle 1 day 1 of docetaxel cisplatin and 5-FU (TPF)
Platelet count >= 100 x 10^9/l at cycle 1 day 1 of TPF
Hemoglobin >= 10 g/dl at cycle 1 day 1 of TPF
Platelets >= 100,000/mcL, during screening and on cycle 1, day 1
Has an active infection requiring systemic therapy which is not expected to have resolved by cycle 1 day 1 dosing
Patients who have had an active infection requiring systemic therapy =< 7 days prior to day -14 are not eligible UNLESS they are symptom-free and have a negative culture at the time of dosing on day -14
Treatment within 12 months of cycle 1 day 1 with any Cyp17-lyase inhibitor, any 2nd generation AR antagonist (e.g. enzalutamide), cabazitaxel or carboplatin
Patients whose disease is refractory (defined as evidence of disease progression while on drug or within 3 months of its discontinuation) to more than 2 lines of chemotherapy; any number of chemotherapies to which the patient’s disease is not refractory are allowed, as long as time on treatment did not exceed 6 months (counted from day 1 of cycle 1 to day 1 of the last cycle of treatment)
Flutamide (Eulexin) treatment within 4 weeks of cycle 1, day 1 and bicalutamide (Casodex) or nilutamide (Nilandron) within 6 weeks of cycle 1 day 1 (exceptions: if progression is documented prior to this time interval, or if patient is deemed by the treating physician to be highly unlikely to respond to AR inhibitor withdrawal (e.g. if PSA did not decline for 3 months in response to AR inhibitor given as a second line or later intervention, or if patient has symptoms attributable to disease progression) only a 3 day washout prior to cycle 1, day 1 will be required for any of them
Current or recent (within 10 calendar days prior to cycle 1, day 1) use of dipyridamole, ticlopidine, clopidogrel, or cilostazol
Treatment with an investigational therapeutic within 30 days of cycle 1
Availability of a frozen biopsy core prior to cycle 1, day 1
Administration of an investigational therapeutic within 30 days of cycle 1, day -2
Chemotherapy or hormonal therapy for anti-cancer treatment within 28 days prior to Cycle 1 Day 1.
Immunotherapy or biological therapy (e.g., monoclonal antibodies) within 28 days prior to Cycle 1 Day 1, unless pre-approval is obtained from the Sponsor Medical Monitor.
Treatment with unapproved investigational therapeutic agent within 28 days prior to Cycle 1 Day 1, unless pre-approval is obtained from the Sponsor Medical Monitor.
Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle 1 Day 1 is not permitted.
Subjects screened between 1 to 12 weeks after last cycle of chemotherapy
Patients must be beyond day 30 and before day 75 after transplant
Chemotherapy or immunotherapy or any other anticancer therapy =< 3 weeks prior to cycle 1 day 1; hydroxyurea may be continued until 72 hours prior to first dose and at least 24 hours before the baseline bone marrow aspiration is performed
Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to day 1 of cycle 1; patients are permitted to be on dabrafenib and trametinib standard of care at start of therapy without wash-out period prior to day 1 of cycle 1; dosing will change to protocol determined dose levels on day 1 of cycle 1
Prior systemic treatment with an azole anti-fungal drug (e.g. fluconazole, itraconazole) within 4 weeks of cycle 1, day 1
Administration of an investigational therapeutic within 30 days prior to cycle 1, day 1
Patients must be willing to use the Optune device >= 18 hours/day for at least 23 days in a 28-day cycle, and keep head shaved throughout treatment
Histologically confirmed solid tumor malignancy for which platinum-based chemotherapy on a 21-day cycle or 14 day cycle is being recommended
Chemotherapy within 3 weeks of Cycle 1 Day 1
Severe infection within 4 weeks prior to Day 1 of Cycle 1
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1 (localized radiation to a single site at least 1 week before cycle 1 day 1 is permissible)
Minimum intervals required to be off treatment prior to Cycle 1 Day 1:
Cancer-related exclusion criteria:\r\n* Patients with known MSI-high status or unknown MSI status are not eligible for study entry\r\n* Patients with BRAF V600E mutations are not eligible for the study\r\n* Surgical procedure (surgical resection, wound revision or any other major surgery) or significant traumatic injury within 60 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study. Minor surgical procedure within 7 days (including placement of a vascular access device) of study cycle 1 day 1\r\n** Study-related biopsies are NOT considered surgical procedures under the exclusion criteria\r\n* Untreated central nervous system (CNS) metastases. Treatment of brain metastases, either by surgical or radiation techniques, must have been completed at least 4 weeks prior to initiation of study treatment\r\n* Treatment with any investigational agent or approved therapy within 21 days (cycle 1 day 1)\r\n* Malignancies other than CRC within 3 years prior to cycle 1 day 1 with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)\r\n* Prior radiation therapy within 14 days prior to study cycle 1 day 1 and/or persistence of radiation-related adverse effects. However, palliative radiation therapy (as long as it does not involve target lesions) is permitted on the study\r\n* Prior allogeneic bone marrow transplantation or solid organ transplant for another malignancy in the past\r\n* Spinal cord compression not definitively treated with surgery and/or radiation\r\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\r\n* Uncontrolled tumor related pain. Patients who require narcotic pain medication during screening should be on a stable dose regimen prior to cycle 1 day 1
Exclusion criteria based on organ function or medical history:\r\n* History of clinically significant cardiac or pulmonary dysfunction including the following:\r\n** Inadequately controlled hypertension (that is defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg that is treated or untreated)\r\n** History of myocardial infarction within 6 months prior to first dose of study drug in cycle\r\n** Prior history of hypertensive crisis or hypertensive encephalopathy\r\n** History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or non-infectious pneuomonitis requiring steroids\r\n* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of cycle 1 day 1\r\n* History of stroke or transient ischemic attack within 6 months prior to cycle 1 day 1\r\n* Serious non-healing wound, active ulcer or untreated bone fracture\r\n* History of abdominal fistula or gastrointestinal perforation within 6 months prior to cycle 1 day 1\r\n* History of hemoptysis (?one teaspoon of bright red blood per episode), or any other serious hemorrhage or at risk of bleeding (gastrointestinal history of bleeds, gastrointestinal ulcers, etc.). INR > 1.5 and aPTT > 1.5 x ULN within 7 days prior to cycle 1 day 1. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding\r\n* Life expectancy of < 12 weeks\r\n* Any previous venous thromboembolism >= grade 3\r\n* Proteinuria at screening as demonstrated by urine dipstick >= 2+ or 24-hour. proteinuria > 1.0 g\r\n* Left ventricular ejection fraction (LVEF) below institutional lower limit of normal\r\n* Uncontrolled serious medical or psychiatric illness\r\n* Pregnant or lactating, or intending to become pregnant during the study. Women who are not post-menopausal (>= 12 continuous months of amenorrhea with no identified cause other than menopause) or surgically sterile must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1
Patients must have cHL that has not been previously treated (patients who have received one dose [day 1 cycle 1] of standard doxorubicin hydrochloride [adriamycin], bleomycin, vinblastine and dacarbazine [ABVD] or doxorubicin hydrochloride, vinblastine, dacarbazine [AVD] may be enrolled as long as they completed all the required standard of care baseline studies before enrollment and initiate study therapy by day 15 cycle 1)
At cycle 1 day 1 pre-dosing: Creatinine > 2 x ULN
Surgery or local prostatic intervention (excluding a prostatic biopsy) less than 28 days of Cycle 1 Day 1.
Pediatric patients ? 1 day old on Cycle 1 Day 1 (C1D1)
Immunosuppressive therapy within 6 weeks of Cycle 1, Day 1
Maintenance should commence within 60 days of recovery of peripheral blood counts after consolidation cycle 2; patients must begin consolidation cycle 2 within 60 days of recovery to be eligible for further therapy
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Immunosuppressive therapy within 6 weeks of Cycle 1, Day 1
Willingness to provide the biologic specimens is required by the protocol; this is part of the mandatory correlative research component; these specimens include:\r\n- PHASE I: peripheral blood for plasma pharmacokinetic analysis and peripheral blood mononuclear cell (PBMC) polymer assessment from 0-24 h after drug administration on days 1 and 2 of cycle 1 as well as day 2 of cycle 2; urine for assessment of ABT-888 renal clearance for 24 h after administration of drugs on days 1 and 2 of cycle 1 as well as day 2 of cycle 2; and a pretreatment peripheral blood sample for possible sequencing of the BRCA1, BRCA2 loci as well as possible pharmacogenomic analysis
Participants who have undergone a major surgical procedure or trauma within 4 weeks prior to cycle 1, day 1; all wounds must be fully healed on cycle 1, day 1
Patients who have had chemotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy within 2 weeks prior to cycle 1 day 1; patients who have had tyrosine kinase inhibitors (such as Braf or MEK inhibitors) within 15 days of cycle 1 day 1
Radiation, chemotherapy, or immunotherapy or any other approved anticancer therapy =< 2 weeks prior to cycle 1 day 1
Participation in an investigational anti-cancer study within 3 weeks prior to cycle 1 day 1
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1 or radio-immunotherapy =< 4 weeks prior to cycle 1 day 1
Participants who are untreated or who received a maximum of one (1) cycle of combination chemotherapy, including rituximab-containing regimens, prior are eligible; the start of previous chemotherapy cycle must occur at least 21 days prior to beginning treatment under this protocol, and such cycle will count towards the total maximum of 6 cycles under this study
Has had minor surgery (i.e., simple excision, tooth extraction) <7 days prior to the first dose of study drug (Cycle 1, Day 1).
Patient must be randomized within 12 weeks of the first day of the last cycle of chemotherapy
Subject has received radiotherapy or radiosurgery within 14 days prior to Cycle 1 Day 1;
Agree to provide core biopsies at baseline and at Cycle 2 Day 15
Receipt of any anti-cancer drug/biologic or investigational treatment within 21 days prior to Cycle 1 Day 1 except hormone therapy, which can be given up to 7 days prior to Cycle 1 Day 1; recovery of treatment related toxicity consistent with other eligibility criteria
Radiation therapy within 2 weeks prior to Cycle 1, Day 1
Patients who have, within 14 days prior to Day 1 dosing:
Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1
Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1
A bone marrow biopsy must be performed within four weeks prior to Cycle 1 Day 1 treatment to establish the baseline fibrosis score;
Patients must have been off of chemotherapy for at least 4 weeks prior to day 1 of cycle 1; informed consent can be signed at any time prior to the start of therapy
Significant cardiac event within 12 months before Cycle 1 Day 1.
Current or recent (within 10 calendar days prior to cycle 1, day 1) use of dipyramidole, ticlopidine, clopidogrel, or cilostazol
For participants with relapsed or refractory FL: prior allogeneic or autologous stem cell transplantation, anthracycline therapy, treatment with fludarabine or alemtuzumab within 12 months prior to Day 1 of Cycle 1, treatment with a monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1, radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Participant has received anti-myeloma treatment within 2 weeks before Cycle 1 Day 1
Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
Deteriorating neurological symptoms, or need for increasing doses of corticosteroids or new onset of seizures between the screening assessment and cycle 1 day 1
Any approved anti-cancer therapy within 3 weeks prior to enrollment with the following exceptions: \r\n* Palliative radiotherapy for bone metastases must be completed > 7 days prior to baseline imaging and > 21 days prior to cycle 1 day 1 of treatment\r\n* Hormone replacement therapy or oral contraceptives are permitted \r\n* Administration of intravesical bacillus Calmette-Guerin (BCG) > 4 weeks before cycle 1, day 1 is allowed
Subject consents to hospitalization for first (Cycle 1 Day 1) dose of CC-90002 and for 72 hours after.
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 3 weeks prior to cycle 1 day 1; treatment with mitomycin C or radio-immunotherapy must be completed within 6 weeks prior to cycle 1 day 1
Participation in an investigational anti-cancer study within 3 weeks prior to cycle 1 day 1
Chemotherapy, or immunotherapy for the treatment of prostate cancer within 4 weeks of Treatment Cycle 1, Day 1
Chemotherapy (approved or investigational) within 3 weeks prior to the first day of treatment or antibody therapy within 6 weeks prior to the first day of treatment
Received crizotinib within 3 days of the first dose of brigatinib (Day 1, Cycle 1).
Thromboembolism within 6 months of cycle 1, day 1
Strontium-89, samarium-153, or radium-223 therapy within 4 weeks of cycle 1, day 1
No treatment with cytotoxic therapy or monoclonal antibodies within 21 days prior to cycle 1 day 1
No treatment with a steroid intended to treat myeloma within 14 days prior to cycle 1 day 1
Radiation therapy for treatment of the primary tumor within 6 weeks of cycle 1, day 1
Radiation or radionuclide therapy for treatment of metastatic CRPC tumor within 2 or 6 weeks, respectively, of cycle 1, day 1
Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of cycle 1, day 1
Prior flutamide (Eulexin) treatment within 4 weeks of cycle 1, day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to cycle 1, day 1)
Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of cycle 1 day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to cycle 1, day 1)
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Subjects must have platelet count greater than 25,000 per microliter at baseline and at the start of study (day 1, cycle 1) visit
Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of cycle 1, day 1
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Administration of an investigational therapeutic drug within 30 Days of Cycle 1 Day 1
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
Radiotherapy or systemic therapy within 2 weeks of Cycle 1 Day 1 (C1D1)
Cytotoxic therapy or monoclonal antibodies within 21 days prior to cycle 1 day 1
Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
Peripheral white blood cell (WBC) count 30,000/µL For cyto-reduction, hydroxyurea is allowed during screening and up to Cycle 1, Days 1-14, to reduce WBC count to < 30,000 µL prior to Day 1. After Cycle 1, Day 14, hydroxyurea is prohibited.
In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines; if day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
Prior treatment with dose dense regimens of temozolomide is not allowed (e.g, 7 days on/7 days off, 21 day/28 day and daily low dose continuous dosing). However, prior treatment with standard day 1-5 dosing in the adjuvant setting and low dose daily dosing as part of chemoradiation therapy are allowed
At least 4 weeks must elapse between the completion of the last chemotherapy, immunotherapy, glucocorticoid therapy, radiotherapy or experimental therapy and administration of the first vaccine; completion is defined as last day of any treatment/therapy, not last day of last cycle
Use of systemic corticosteroids ? 2 weeks before Cycle 1 Day 1.
Received the last dose of previous treatment / therapy before Day 1 of cycle 1:
Subject has the following blood chemistry levels at screening (obtained ? 14 days prior to starting Cycle 1 Day 1):
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ? 2 weeks prior to Cycle 1 Day 1, except ibrutinib which may be continued until one day prior to initiation of selinexor; radio-immunotherapy 4 weeks prior to Cycle 1 Day 1. Patients must have recovered to Grade ? 1 from clinically significant adverse effects.
At least 21 days must have elapsed prior to Day 1 Cycle 1, since any radiotherapy, immunotherapy or following major surgery; any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 since \limited palliative radiotherapy\, defined as a course of therapy encompassing <25% total bone marrow volume and not exceeding 30 GY.
Patients who have had any chemotherapy regimens, biologic, or targeted therapies within the 2 weeks prior to Cycle 1 Day 1
Any malignancy within 5 years prior to Cycle 1, Day 1
Prior systemic treatment with an azole drug (fluconazole, itraconazole) within 4 weeks of cycle 1 day 1.
Anti-cancer therapy within the period immediately before Cycle 1 Day 1
Malignancies other than UC within 5 years prior to Cycle 1, Day 1
Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/day for more than 1 day out of 7 days
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1; any clinical trial therapy (including investigational anti-cancer study) =< 3 weeks prior to cycle 1 day 1
Significant cardiovascular or cerebrovascular disease within 6 months prior to Day 1 of Cycle 1
Systemic cytotoxic therapies or radiotherapy ?14 days prior to day 1 cycle 1
For two weeks prior to day 1 cycle 1, administration of specified cytochrome P450 3A (CYP3A) inducers
Patients who have been treated with an investigational agent <21 days prior to day 1 of cycle 1
Administration of an investigational therapeutic within 30 days of cycle 1, day 1
At least 21 days must have elapsed prior to day 1 cycle 1, from chemotherapy, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for \limited palliative radiotherapy\, defined as a course of therapy encompassing < 25% total bone marrow volume and not exceeding 30 Gy.
Adequate bone marrow, liver, and renal function within the 14 days prior to Day 1 of Cycle 1 of study drug up until pre-dose of Cycle 1
Participants with persistent phosphate greater than upper limit of normal during screening (within 14 days prior to Day 1 of Cycle 1 up until pre-dose of Cycle 1) and despite medical management of phosphate levels
Neutrophil count < 1.5 × 10^9/liter (L) prior to dosing on Cycle 1 Day 1
Platelet count ? 150 × 10^9/L prior to dosing on Cycle 1 Day 1
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ?3 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1;
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ?2 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1.
Prior anti-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
?2 weeks for cytotoxic therapy (except hydroxyurea, which is permitted at doses of ?5g/day during the first 2 weeks of Cycle 1) prior to C1D1.
Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1
Participation in an investigational anti-cancer study =< 3 weeks prior to cycle day 1
CYCLE II PORTION ONLY: Only participants with a nausea score >= 3 at least once on the diary assessment from cycle 1 can be randomized for cycle 2
CYCLE II PORTION ONLY: Participants must be scheduled to receive the same chemotherapy regimen as received at cycle 1
CYCLE II PORTION ONLY: Must not have received Akynzeo at cycle 1
CYCLE II PORTION ONLY: Must still meet all the exclusion criteria for cycle 1
Planned administration of an investigational study drug or agent that either can interact with pamidronate or have an independent effect on bone mineral density within the 4 weeks prior to randomization (day 90) or planned use during study participation (day 90 through day 360)
7th or later cycle of intravenous carboplatin or oxaliplatin infusion planned or 4 months after the first cycle of agent (whichever is of longer duration) =< 30 days after registration
Study participation will occur during the first cycle of 5 day temozolomide course
History of intra-abdominal inflammatory process within 6 months prior to Day 1 of Cycle 1
Treatment with any HCV anti-viral therapy within 4 weeks prior to Cycle 1 Day 1
Prior anti-cancer therapy within 4 weeks prior to Cycle 1, Day 1
Describe fatigue as being present every day for most of day for a minimum of 2 weeks
Describe fatigue as being present every day for most of the day for a minimum of 2 weeks
If currently menstruating, must know the date of the first day of their latest menstrual cycle
Inclusion Criteria:\n\n        Cycle 1:\n\n        The following inclusion criteria must be checked prior to inclusion at Cycle 1:\n\n          1. Patient read, understood and signed the written informed consent before any study\n             related activity, agreeing to participate in the study and to comply with study\n             requirements.\n\n          2. Female patient of at least 8 years of age.\n\n          3. Histologically or cytologically confirmed breast cancer, including recurrent or\n             metastatic.\n\n          4. Naïve to moderately or highly emetogenic antineoplastic agents.\n\n          5. Scheduled to receive at least 4 consecutive cycles of an AC combination regimen.\n\n             Notes:\n\n               1. additional not emetogenic, minimally or low emetogenic antineoplastic agents are\n                  permitted at any time after start of AC combination on Day 1.\n\n               2. additional highly or moderately emetogenic antineoplastic agents are only allowed\n                  on Day 1 after the start of AC combination, provided their administration is\n                  completed within 6 hours from the start of the AC combination administration.\n\n          6. ECOG Performance Status of 0 or 1.\n\n          7. Patient shall be: a) of non-childbearing potential or b) of childbearing potential\n             using reliable contraceptive measures and having a negative urine pregnancy test\n             within 24 hours prior to dose of investigational product.\n\n             Notes:\n\n               1. Female patients of non-childberaring potential are defined as being in\n                  post-menopausal state since at least 1 year; or having documented surgical\n                  sterilization or hysterectomy at least 3 months before study participation.\n\n               2. Reliable contraceptive measures include implants, injectables, combined oral\n                  contraceptives, intrauterine devices, vasectomized partner or complete (long\n                  term) sexual abstinence;\n\n          8. Hematologic and metabolic status adequate for receiving a cycle of AC chemotherapy\n             based on investigator's assessment.\n\n          9. If the patient has a known hepatic or renal impairment, she may be enrolled in the\n             study at the discretion of the Investigator.\n\n         10. Able to read, understand, follow the study procedure and complete the patient diary.\n\n        All inclusion criteria will be checked at screening visit (Visit 1 of Cycle 1); inclusion\n        criteria 7 will be re-checked at Day 1 (Visit 2).\n\n        Cycles 2 to 4:\n\n        The following inclusion criteria must be checked prior to inclusion at each repeated cycle:\n\n          1. Participation in the study during the next cycle of chemotherapy is considered\n             appropriate by the Investigator and does not pose unwarranted risk to the patient.\n\n          2. Scheduled to receive an AC chemotherapy regimen or AC chemotherapy together with other\n             chemotherapies as defined in Inclusion criterion #5 for Cycle 1.\n\n          3. Patient shall be: a) of non-childbearing potential or b) of childbearing potential\n             using reliable contraceptive measures and having a negative urine pregnancy test\n             within 24 hours prior to dosing of investigational product.\n\n          4. Adequate hematologic and metabolic status for receiving a cycle of AC chemotherapy\n             according to the Investigator's opinion.\n\n        All inclusion criteria will be checked at screening visit (Visit 1); inclusion criterion #3\n        will be re-checked at Day 1 (Visit 2).\n\n        Exclusion Criteria:\n\n        Cycle 1:\n\n        The following exclusion criteria must be checked prior to inclusion at Cycle 1:\n\n          1. Lactating patient.\n\n          2. Current use of illicit drugs or current evidence of alcohol abuse.\n\n          3. Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition\n             to the AC regimen, from 6 hours after the start of the AC chemotherapy on Day 1 and up\n             to Day 1 of Cycle 2.\n\n          4. Received or is scheduled to receive radiation therapy to the abdomen or the pelvis\n             within 1 week prior to the start of AC chemotherapy administration on Day 1 or between\n             Days 1 to 5, inclusive.\n\n          5. Any vomiting, retching, or nausea (grade 1 as defined by National Cancer Institute)\n             within 24 hours prior to the start of AC chemotherapy administration on Day 1.\n\n          6. Symptomatic primary or metastatic central nervous system (CNS) malignancy.\n\n          7. Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial\n             pressure, hypercalcemia, an active infection or any illness or medical conditions\n             (other than malignancy) that, in the opinion of the Investigator, may confound the\n             results of the study, represent another potential etiology for emesis and nausea\n             (other than chemotherapy-induced nausea and vomiting [CINV]) or pose unwarranted risks\n             in administering the study drugs to the patient.\n\n          8. Known hypersensitivity or contraindication to 5 hydroxytryptamine type 3 (5-HT3)\n             receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron,\n             tropisetron, ramosetron), to dexamethasone, or to neurokinin-1 (NK1) receptor\n             antagonists (e.g., aprepitant, rolapitant).\n\n          9. Known contraindication to the IV administration of 50 mL 5% glucose solution.\n\n         10. Participation in a previous clinical trial involving IV fosnetupitant or oral\n             netupitant administered alone or in combination with palonosetron.\n\n         11. Any investigational drugs taken within 4 weeks prior to Day 1, and/or is scheduled to\n             receive any investigational drug (other than those planned by the study protocol)\n             during the present study.\n\n         12. Systemic corticosteroid therapy within 72 hours prior to the start of AC chemotherapy\n             administration on Day 1, except the dexamethasone provided as additional study drug.\n             However, topical and inhaled corticosteroids are permitted.\n\n         13. Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy\n             during the study participation.\n\n         14. Other than as administered as part of the study protocol, any medication with known or\n             potential antiemetic activity within 24 hours prior to the start of AC chemotherapy\n             administration on Day 1, including:\n\n               -  5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron,\n                  tropisetron, ramosetron, palonosetron)\n\n               -  NK1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant or any\n                  other new drug of this class)\n\n               -  benzamides (e.g., metoclopramide, alizapride)\n\n               -  phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine,\n                  thiethylperazine, chlorpromazine)\n\n               -  benzodiazepines (except if the subject is receiving such medication for sleep or\n                  anxiety and has been on a stable dose for at least seven days prior to Day 1).\n\n               -  butyrophenones (e.g., haloperidol, droperidol)\n\n               -  anticholinergics (e.g., scopolamine, with the exception of inhaled\n                  anticholinergics for respiratory disorders, e.g., ipratropium bromide)\n\n               -  antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine, chlorpheniramine)\n\n               -  domperidone\n\n               -  mirtazapine\n\n               -  olanzapine\n\n               -  prescribed cannabinoids (e.g., tetrahydrocannabinol or nabilone)\n\n               -  Over The Counter (OTC) antiemetics, OTC cold or OTC allergy medications.\n\n         15. Scheduled to receive any strong or moderate inhibitor of CYP3A4 during the efficacy\n             assessment period (Day 1 to Day 5, inclusive) or its intake within 1 week prior to Day\n             1.\n\n         16. Scheduled to receive any CYP3A4 inducer during the efficacy assessment period (Day 1\n             to Day 5, inclusive) or its intake within 4 weeks prior to Day 1, with the exception\n             of corticosteroids (for which exclusion criterion #12 applies).\n\n         17. History or predisposition to cardiac conduction abnormalities, except for incomplete\n             right bundle branch block.\n\n         18. History of risk factors for Torsades de Pointes (heart failure, hypokalemia, family\n             history of Long QT Syndrome).\n\n         19. Severe or uncontrolled cardiovascular diseases, including myocardial infarction within\n             3 months prior to Day 1, unstable angina pectoris, significant valvular or pericardial\n             disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure\n             (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial\n             hypertension.\n\n        All exclusion criteria with the exception of criteria #5, #12, and #14 will be checked at\n        screening visit (Visit 1). Exclusion criteria #5, #12, and #14 will be checked at Day 1\n        (Visit 2) only.\n\n        Exclusion criteria #3, #4, #7, #11, #13, #15, and #16 need to be re-checked at Day 1 (Visit\n        2).\n\n        Cycles 2 to 4:\n\n        The following exclusion criteria must be checked prior to inclusion at each repeated cycle:\n\n          1. Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition\n             to the AC regimen, from 6 hours after the start of the AC chemotherapy on Day 1 of\n             current cycle and up to Day 1 of the next cycle.\n\n          2. Active infection or uncontrolled disease that may pose unwarranted risks in\n             administering the study drugs to the patient.\n\n          3. Started any of the prohibited medications.\n\n          4. Any vomiting, retching, or nausea (grade ? 1 as defined by National Cancer Institute)\n             within 24 hours prior to the start of AC chemotherapy administration on Day 1.\n\n          5. Received or is scheduled to receive radiation therapy to the abdomen or the pelvis\n             within 1 week prior to the start of AC chemotherapy administration on Day 1 or between\n             Days 1 to 5.\n\n          6. Symptomatic primary or metastatic CNS malignancy.\n\n          7. Any illness or medical condition that, in the opinion of the investigator, may\n             confound the results of the study or pose unwarranted risks in administering the\n             investigational product or dexamethasone to the patient.\n\n        All exclusion criteria, with exception of criterion #4, will be checked at screening visit\n        (Visit 1). Exclusion criterion #4 will be checked at Day 1 (Visit 2) only. Exclusion\n        criteria #2, #3 and #5 need to be re-checked at Day 1 (Visit 2).
Women who are using postmenopausal hormones, and are planning to continue the same regimen through surgery are eligible to participate; if the hormone therapy regimen is cyclical, the following should be recorded regarding the day of baseline core biopsy and day of surgery: the agent, the day of the phase (e.g. day 13 of 14-day estrogen phase etc); this information will have to be back-calculated for the day of core biopsy, but best attempt should be made
?100% increase in WBC count (myeloid cell line and monocyte series) within the 8-week period leading to Cycle 1, Day 1
Last anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks prior to study day 1 or treatment with a therapeutic antibody less than 4 weeks prior to study day 1 as well as systemic radiation therapy within 28 days prior to study day 1 or focal radiotherapy within 14 days prior to study day 1.
Patient must start everolimus 10mg plus exemestane 25mg treatment on Cycle 1 Day 1 of trial
Washout period prior to Day 1 Cycle 1:
Patients must have had treatment with temozolomide, lomustine (CCNU) or PCV (procarbazine, lomustine [CCNU], vincristine) chemotherapy prior to histopathologic transformation to glioblastoma or prior to identification of one of the genetic alterations specified; notes or records from the treating oncologist are required for documentation of treatment history; prior treatment with at least one of the following chemotherapy schedules is required to be eligible:\r\n* At least one 6 week course of continuous daily temozolomide\r\n* At least six 28-day cycles given in one of the following schedules:\r\n** Daily for 5 days of a 28-day cycle\r\n** Daily for 21 days of a 28-day cycle\r\n** Daily for 14 days of a 28-day cycle\r\n** Alternating 7 days on/7 days per 28-day cycle\r\n** Continuous daily dosing of a 28-day cycle\r\n* Other schedules of temozolomide may be considered after discussion with the overall principal investigator\r\n* At least 3 cycles of PCV or lomustine (CCNU) chemotherapy
Subject has received other investigational therapy within the last 28 days.
Patients who are receiving any other concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy as defined as treatment for which there is currently no regulatory authority approved indication) will not be eligible
Treatment with any of the following therapies: \r\n* Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib hydrochloride OR\r\n* Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib\r\n* Patients who require chronic use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers including but not limited to grapefruit juice
Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and/or dexamethasone, or one dose of cytarabine) prior to starting therapy
Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 4 weeks prior to the initiation of study drug.
Use of any investigational agent. Use and/or receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal anti-bodies) within 14 days prior to the first dose of study therapy.
Biologic (anti-neoplastic agent): patients must be at least 7 days since the completion of therapy prior to registration
Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note: some cohort exceptions allow anti-PD-1 therapy)
Treatment with clarithromycin, anti-myeloma therapy including investigational agents or plasmapheresis within 15 days prior to treatment in this study
Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biological agent
Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 4 weeks prior to the initiation of study drug administration.
Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 halflives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in question prior to the day of dosing with the PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, retinoid therapy, or investigational agent) within 14 days or 5 half-lives of day 1
Other anti-neoplastic investigational agents currently or within 2 weeks prior to apheresis (i.e. start of protocol therapy)
Patients may not be receiving any other investigational agents during protocol therapy, or up to 30 days prior to beginning protocol therapy; there should be a least a 1-week interval between last dose of endocrine therapy and protocol therapy, and at least 3 weeks for the last dose of biologic therapy (eg, bevacizumab) or cytotoxic therapy (or 2 weeks for capecitabine or weekly paclitaxel, 6 weeks for mitomycin-C and nitrosoureas), and adequately recovered from adverse effects from prior therapy to meet all other eligibility criteria
No concurrent anticancer therapy. Required washout from prior therapy:\r\n* Endocrine therapy: no required wash-out\r\n* Chemotherapy: 14 days\r\n* Major surgery: 14 days (provided wound healing is adequate)\r\n* Radiation: 7 days\r\n* Investigational/biologic therapy (half-life =< 40 hours): 14 days\r\n* Investigational/biologic therapy (half-life > 40 hours): 28 days.
Subject has received biologic agents (e.g. monoclonal antibodies) for anti-neoplastic intent within 30 days prior to first dose of study drug
Other anti-neoplastic investigational agents currently or within 30 days prior to apheresis (i.e. start of protocol therapy)
Received investigational therapy (e.g. small molecule or biologic) within 30 days prior to the start of CMP-001 dosing on W1D1. However, if an investigational therapy has a short half-life, a reduced wash out period may be acceptable with Sponsor approval. Acceptable washout periods include:
Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.
Biologic (anti-neoplastic agent)
Treatment with investigational therapy within 28 days prior to randomisation
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 14 days of registration
Prior systemic cytotoxic therapy, antineoplastic biologic therapy, or major surgery within 28 days of first dose of study medication
Any other anticancer therapy (e.g., chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy, investigational agent) within 28 days of the first dose of study therapy (and within 6 weeks for nitrosourea or mitomycin C) other than a single dose of intravesical chemotherapy which is permitted between 28 days and 14 days prior to the first dose of study treatment
Biological (anti-neoplastic) therapy: ? 7 days prior to screening.
Chemotherapy, immunotherapy, targeted therapy, monoclonal antibodies, tumor embolization, or other investigational agent within 28 days prior to the first dose of study drug
Receipt of the last dose of anti-cancer therapy (immunotherapy, endocrine therapy [e.g., abiraterone acetate, enzalutamide], targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 28 days prior to the first dose of study drug. (with the exception of any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA4, including tremelimumab.)
Prior antitumor therapy as follows, before the first dose of study drug: Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; Monoclonal antibody treatment for multiple myeloma within 21 days; Cytotoxic therapy within 21 days; Proteasome inhibitor therapy within 14 days; Immunomodulatory agent therapy within 7 days; Radiotherapy within 21 days. However, if the radiation portal covered less than or equal to (<=) 5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy
Anti-cancer therapy, including an investigational agent, less than 14 days prior to the first dose of nivolumab
Receipt of the last dose of anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 28 days prior to the first dose of study drug (28 days prior to the first dose of study drug for subjects who have received prior tyrosine kinase inhibitors [TKIs] [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C [if sufficient wash-out time has not occurred due to the schedule or pharmacokinetic [PK] properties of an agent, a longer wash-out period may be required])
Major surgery (including breast surgery) within < 30 days of starting treatment or received chemotherapy, investigational agents, or other cancer therapy < 14 days prior to the initiation of investigational products (except adjuvant endocrine therapy)
Prior chemotherapy or radiotherapy within 14 days prior to first dose of therapy provided subject has received no growth factor support of any kind within 28 days prior to first dose of therapy, otherwise prior chemotherapy within 28 days prior to first dose of therapy
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, gamma-knife, other investigational agent) =< 14 days prior to the first dose of study drug; for WBRT, the washout period is 28 days; local treatment of isolated lesions for palliative radiation therapy (RT) (by radiotherapy, for example) is acceptable
Received any of the following prior anticancer therapy:\r\n* Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT); Note: stereotactic radiosurgery (SRS) is allowed\r\n* Non-antiangiogenic therapy (including investigational agents and small molecular kinase inhibitors) within 7 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug\r\n* Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug\r\n* Nitrosoureas or mitomycin C within 42 days or metronomic/protracted low- dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\r\n* Prior treatment with TVB-2640\r\n* Prior treatment with Carmustine Wafers
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 28 days prior to the first dose of study drug (=< 21 days prior to the first dose of study drug for subjects who have received prior tyrosine kinase inhibitors (TKIs) [e.g., erlotinib, gefitinib and crizotinib] and =< 6 weeks for nitrosourea, mitomycin C, or bevacizumab). (If sufficient wash-out time has not occurred due to the schedule or pharmacokinetics (PK) properties of an agent, a longer wash-out period may be required.)
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 21 days prior to the first dose of study drug
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, radiotherapy or other investigational agent) =< 21 days prior to the first dose of study drug and within 6 weeks for nitrosourea or mitomycin C)
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, tyrosine kinase inhibitor, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 30 days prior to the first dose of study drug and within 6 weeks for nitrosourea, mitomycin C or intravesical therapy)
Any of the following therapies prior to registration:\r\n* Chemotherapy =< 21 days\r\n* Immunotherapy =< 21 days\r\n* Biologic therapy =< 21 days\r\n* Hormonal therapy =< 14 days\r\n* Monoclonal antibodies =< 14 days\r\n* Radiation therapy =< 14 days\r\n* Minor surgical or interventional procedure =< 7 days\r\n• Major surgical procedure =< 21 days
Receipt of any anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) within the last 6 months (mo) (before the first dose of durvalumab)
Recent prior therapy, defined as 1. Any non-monoclonal anti-cancer therapy within 14 days or 5 half-lives, whichever is longer, prior to the first dose of GSK3326595. Any nitrosoureas or mitomycin C within 42 days prior to the first dose of GSK3326595. Prior therapy with biologic agents (including monoclonal antibodies) is permitted so long as 28 days have elapsed since therapy and all therapy-related AEs have resolved to =< Grade 1, 2. Any radiotherapy within 14 days or major surgery within 28 days prior to the first dose of GSK3326595. For subjects in the GBM cohort, subjects must have completed radiation therapy at least 28 days prior to the first dose of GSK3326595. 3. Anti-androgen therapies for prostate cancer, such as bicalutamide, must be stopped 4 weeks prior to enrollment. Second-line hormone therapies such as enzalutamide or abiraterone should be stopped 2 weeks prior to enrolment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone [up to 10 milligram (mg)/day] and still be eligible for this study.
Other investigational therapy (within 30 days of Study Day 1).
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 14 days prior to the first dose of study drug (=< 7 days or four half-lives, whichever is longer, prior to the first dose of study drug for subjects who have received prior tyrosine kinase inhibitors [TKIs] [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C)
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 30 days prior to the first dose of study drug 30 days prior to the first dose of study drug for subjects who have received prior tyrosine kinase inhibitors (TKIs) (e.g., erlotinib, gefitinib and crizotinib) and within 6 weeks for nitrosourea or mitomycin C
Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents
Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents
Subject has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or herbal therapy within 7 days prior to the first dose of ABBV-399.
A biologic agent (i.e., monoclonal antibodies) for anti-neoplastic intent within 30 days
Steroid therapy for anti-neoplastic intent within 5 days
Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled 90Y therapy dose
Treatment with any of the following anti-cancer therapies:\r\n* Radiation therapy, surgery, or tumor embolization within 14 days prior to the first dose of pazopanib OR\r\n* Chemotherapy, immunotherapy, investigational therapy, or hormonal therapy within 14 days prior to the first dose of pazopanib
Recent Investigational therapy
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
The subject has received any of the following prior anticancer therapy:\r\n* Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site\r\n* Radiation therapy within 12 weeks of screening\r\n* Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (e.g., tamoxifen) within 14 days or 5 half-lives, whichever is shorter, prior first dose of study drug\r\n* Biologic agents (antibodies, immune modulators, vaccines, and cytokines) within 21 days prior to first dose of study drug\r\n* Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\r\n* Prior treatment with carmustine wafers\r\n* Patients who are currently receiving any other investigational agents and/or who have received an investigational agent in the prior 28 days
Last dose of chemotherapy, immunotherapy, biologic therapy, or investigational therapy, was less than 14 days prior to protocol therapy (radiation and veliparib)
Received systemic anticancer therapy (including cytotoxic chemotherapy, investigational agent, antineoplastic monoclonal antibodies, or immunotherapy) ?14 days prior to first dose of AP32788 (except for reversible EGFR TKIs [ie, erlotinib or gefitinib], which are allowed up to 7 days prior to the first dose of AP32788).
Is currently participating and receiving study therapy with potential anti-neoplastic activity, or has participated in a study of an investigational agent and received study therapy with potential anti-neoplastic activity within 4 weeks of the first dose of treatment
Systemic anti-myeloma therapy within <14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
Systemic anti-myeloma therapy (including systemic steroids) within 14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies or other investigational product) =< 28 days; however, if a therapy has a short half-life, then patients may participate if they received prior treatment =< 28 days from starting study treatment with approval from the principal investigator (PI) and AstraZeneca/Janssen; acceptable washout periods include:\r\n* 3-14 days for prior tyrosine kinase inhibitor (TKI) depending on half-life\r\n* 14-28 days for prior PD-1 or PD-L1 inhibitor treatment depending on the frequency of administration (i.e., wait one full cycle of prior PD-1 axis inhibition before starting study drugs)
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) within 28 days prior to the first dose of study drug and within 6 weeks for nitrosourea or mitomycin C
Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 3 weeks prior to the initiation of study drug.
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 28 days prior to the first dose of study drug (=< 28 days prior to the first dose of study drug for subjects who have received prior tyrosine kinase inhibitors [TKIs] [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C); (if sufficient wash-out time has not occurred due to the schedule or pharmacokinetics [PK] properties of an agent, a longer wash-out period may be required)
Patients must not have received the therapies indicated below for the specified time period prior to the first day of administration of protocol therapy on this study\r\n* Myelosuppressive chemotherapy: must have received last dose at least 2 weeks prior to protocol therapy; this includes cytotoxic agents given on a low dose metronomic regimen\r\n* Biologic (anti-neoplastic agent) (includes retinoids): must have received last dose at least 7 days prior to protocol therapy\r\n* Monoclonal antibodies: must have received last dose at least 7 days or 3 half-lives, whichever is longer, prior to protocol therapy
Other anti-neoplastic investigational agents currently or within 30 days prior to apheresis (i.e. start of protocol therapy)
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of IPHC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Participant has received radiation therapy to lung greater than 30 Gy within 6 months, or antineoplastic biologic therapy within 21 days, or major surgery within 21 days, or tyrosine kinase inhibitor therapy within 7 days, or palliative radiation within 7 days of the first dose of study medication.
Any investigational therapy within 28 days prior to the first dose of IP.
Any investigational therapy within 28 days prior to the first dose of IP.
Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days prior to study day 1
Concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy
Prior treatments usage as defined: A) Use of an investigational anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of the investigational products:; B) A minimum of 14 days between termination of the investigational drug and administration of GSK525762; C) Any therapy related toxicities must also have resolved to Grade 1 or less. Note that an investigational drug is defined as a drug without an approved oncologic indication; D) Chemotherapy, radiotherapy, anti-neoplastic antibody or targeted therapy or immunotherapy within 14 days, major surgery within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of the investigational product. Anti-androgen (e.g., bicalutamide) therapies for prostate cancer must be stopped 4 weeks prior to enrollment. Second line hormone therapies such as enzalutamide, abiraterone, or orteronel should be stopped 2 weeks prior to enrollment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone (up to 10 mg/day) and still be eligible for this study.
Received anti-neoplastic monoclonal antibodies within 30 days of the first dose of study drug.
Subject has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or anti-cancer herbal therapy within 7 days prior to Cycle 1 Day 1 of ABT-165.
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 21 days prior to the first dose of study drug
Insufficient time for recovery from prior therapy:\r\n* Less than 28 days from WBRT or SRS;\r\n* Less than 28 days from any investigational agent, \r\n* Less than 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine, irinotecan or topotecan administration), and \r\n* Less than 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. \r\n* When radiation necrosis is suspected, standard of care (SOC) confirmatory imaging, such as MRI perfusion, magnetic resonance (MR) spectroscopy and or positron emission tomography (PET) will be performed, and patients with findings consistent with radiation necrosis will be excluded
Received any anti-cancer therapy including chemotherapy or radiotherapy, steroid therapy for anti-neoplastic intent, and investigational therapy, including targeted small molecule agents within 28 days prior to the first dose of study drug or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy
Patients must have sufficient time for recovery from prior therapy: 28 days from any investigational agent, 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc.
Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note: Some cohort exceptions allow anti-PD-1 therapy)
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) < 21 days prior to the first dose of study drug
Recent prior therapy, defined as follows: 1) Any investigational or Food and Drug Administration (FDA)-approved anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of GSK2820151. Any nitrosoureas or mitomycin C within 42 days prior to the first dose of GSK2820151. Prior therapy with monoclonal antibodies is permitted so long as 14 days have elapsed since therapy and all therapy-related toxicity has resolved to Grade 1 or less. Note that an investigational drug is defined as a drug without an approved oncologic indication. 2) Any radiotherapy within 14 days or major surgery within 28 days prior to the first dose of GSK2820151. 3) Anti-androgen therapies for prostate cancer, such as bicalutamide, must be stopped 4 weeks prior to enrollment. Second-line hormone therapies such as enzalutamide, abiraterone, or orteronel should be stopped 2 weeks prior to enrolment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone (up to 10 milligrams [mg]/day) and still be eligible for this study. 4) In addition, any therapy-related toxicity must have resolved to Grade 1 or less, with the exception of alopecia (acceptable at any Grade) and peripheral neuropathy (which must be Grade 2 or less prior to enrollment).
Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents
The subject has received any of the following prior anticancer therapy:\r\n* Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT); Note: stereotactic radiosurgery (SRS) is allowed\r\n* Non-bevacizumab systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug\r\n* Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug, with the exception of bevacizumab which can be 14 days or maintain the subject's current bevacizumab dosing schedule\r\n* Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\r\n* Prior treatment with carmustine wafers\r\n* Prior treatment with TH-302
Must not have received systemic anti-neoplastic therapy, including radiotherapy within 14 days of study treatment
Any major surgery =< 28 days prior to the initiation of investigational products, or received anti-cancer therapy (including chemotherapy, biological therapy, hormonal therapy, investigational agents, or other anti-cancer therapy) administered =< 14 days prior to the initiation of investigational products
Treatment with any of the following anti-cancer therapies:\r\n* Radiation therapy, chemotherapy, immunotherapy, biologic therapy, investigational therapy\r\n* Surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR\r\n* Hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
Patients who have had chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C), radiotherapy within 14 days, biological therapy within 14 days, hormonal therapy within 7 days, and investigational therapy within 21 days prior to enrollment
Patient must not have had chemotherapy, immunotherapy, biologic therapy, hormonal therapy, or investigational therapy within 14 days or 5 half-lives of the drug prior to the first dose of pazopanib; for patients enrolling in the phase I portion of this study, this requirement does not apply to prior treatment with cetuximab
Insufficient time for recovery from prior therapy:\r\n* Less than 28 days from any investigational agent, \r\n* Less than 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and \r\n* Less than 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)
Treatment with any of the following anti-cancer therapies: \r\n* Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR \r\n* Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
Has had any major surgery within the last 28 days, or cytotoxic chemotherapy, biologic therapy, investigational agents, or radiotherapy within the last 21 days and/or has not recovered from prior therapy; patients who have just completed therapy with mitomycin C or nitrosourea will have to wait 42 days before starting therapy
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 14 days prior to the first dose of study drug
Receipt of the last dose of any line of anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, and other investigational agent) 7 days prior to the first dose of study drug and within 6 weeks for nitrosourea or mitomycin C prior radiation therapy to targets other than the site currently being treated is permitted
Received last dose of systemic cytotoxic therapy, radiation therapy or therapy with any investigational product within 28 days of enrollment.
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) < 21 days prior to the first dose of study drug; receipt of the last dose of hormonal therapy within < 7 days prior to the first dose of study drug
Receipt of the last dose or treatment of anti-cancer therapy for the current cancer (chemotherapy, radiotherapy, surgery, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 4 weeks (6 weeks for nitrosoureas or mitomycin C) or > 6 months prior to first dose of study drug
Patients must have sufficient time for recovery from prior therapy: 28 days from any investigational agent, 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and 7 days for patients who received metronomic chemotherapy or non-cytotoxic agents, e.g., bevacizumab, interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count)
Received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, any investigational therapy or herbal therapy within a period of 21 days prior to the first dose of ABBV-838, and have unresolved toxicities ? grade 2
Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days
Last dose of systemic anti-neoplastic therapy > 21 days prior to first RO6927005 infusion
Prior to study treatment administration, at least 21 days must have elapsed since the subject's prior investigational or non-investigational systemic therapy, or any major surgery, and at least 21 days since prior radiotherapy.
Is receiving concurrent standard and/or investigational anti-cancer therapy or has received such therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication); or
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Received any other investigational therapy within 28 days of Day 1; or
Biologic/Immunologic (anti-neoplastic) therapy: It must be at least 28 days since the completion of therapy with a biologic/immunologic agent such as a monoclonal antibody prior to study enrollment and at least 28 days since non-study chemotherapy has been administered, excluding CNS directed therapy as described in Section 4.1.
Received monoclonal antibodies (for any reason), chemotherapy, surgery, investigational therapy, or radiotherapy within 14 days of the first dose of mogamulizumab;
An investigational therapy.
Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
At least 7 days since the completion of therapy with a biologic agent
Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents
Subject has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug
Investigational therapy or any other therapy =< 28 days before first study treatment
Biologic (anti-neoplastic agent including retinoids): Last dose given at least 7 days prior to the start date for protocol therapy.
Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days
Steroid therapy for anti-neoplastic intent within 5 days
Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy greater than 60 days prior to receiving the first injection of DPX-Survivac
Received prior investigational or non-investigational cytotoxic chemotherapy, hormonal therapy, biological therapy (including but not limited to monoclonal antibodies, small molecules or other immunotherapy) to treat hepatocellular carcinoma.
Anti-tumor therapy within 28 days of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent
Prior treatment with cytotoxic anti-cancer therapy (previous cytokine or investigational immunotherapy are permitted, but must be completed 28 days prior to first dose of study medication)
The subject is receiving concomitant radiotherapy, chemotherapy, other anti-neoplastic therapy, or investigational therapy (other than the investigational therapy under study)
The subject has received radiation therapy, chemotherapy, other anti-neoplastic therapy, or investigational therapy within 30 days prior to first dose of study drug
Biologic (anti-neoplastic) agent: At least 7 days since the completion of therapy with a biologic agent; at least 3 half-lives since previous monoclonal antibody therapy
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 28 days prior to the first dose of study drug (if sufficient wash-out time has not occurred due to the schedule or pharmacokinetics [PK] properties of an agent, a longer wash-out period may be required)
The last dose of biologic or investigational therapy must be =< 21 days prior to initiation of study therapy
Participant has received anti-cancer therapy including chemotherapy, immunotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day
Greater than 30 days from completion of cytotoxic and biologic therapy and less than 120 days from previous therapy.
First dose of study medication must be greater than 30 days from completion of cytotoxic and antibody therapy and less than 120 days from previous therapy
Systemic anti-tumor therapy within 14 days, or plasmapheresis within 7 days prior to the first dose of study drug
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) < 21 days prior to enrollment
Anticancer treatment, including endocrine therapy, radiotherapy, chemotherapy, biologic therapy, or therapy in an investigational clinical study, ? 14 days prior to the date of Randomization
Must not have treatment with any of the following anti-cancer therapies:\r\n* Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR\r\n* Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days prior to the first dose of pazopanib\r\n* Treatment with prior sorafenib, sunitinib, temsirolimus or everolimus is allowed but must be discontinued at least 5 days prior to beginning pazopanib
Subject has received any of the following within 14 days or 5 drug half-lives (whichever is shortest) prior to the first dose of chemotherapy, or has not recovered to less than grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy\r\n* Any anti-cancer therapy including chemotherapy, biologic agents for antineoplastic treatment (e.g. monoclonal antibodies) or radiotherapy, investigational therapy, including targeted small molecule agents
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment* (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Biologic: ?7 days from anti-neoplastic biologic agent