No more than 3 prior systemic treatment regimens for advanced PNET
Has received at least 2 prior regimens of standard treatment
Received ? 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment
UCC and SCCHN and salivary gland cancer - No more than three different prior treatment regimens in the advanced/metastatic setting with a maximum of two chemotherapy-containing regimens
Patients may have had up to 3 prior regimens for metastatic disease
Evidence of progressive disease during or following no more than 2 prior chemotherapy regimens
Received 1 or 2 prior standard of care regimens for advanced or metastatic disease
Progressed on or intolerant of at least 2 prior cancer therapy regimens administered for metastatic disease.
Any number of prior treatment regimens
Progressive disease after >= 1 prior chemotherapy regimens
Status post 1 or more unmatched systemic therapy regimens for enrollment to group 3
Progressive disease after 1-3 prior chemotherapy regimens (perioperative chemotherapy within 12 months will be considered one regimen)
There is no limit to the number of prior chemotherapy regimens received; patients must have received at least one line of prior systemic chemotherapy for advanced unresectable and/or metastatic disease
Any number of prior chemotherapy regimens are allowed
Triple negative (ER-/PR-/HER2-) (Note: This group of patients must have received at least 1 and up to 3 prior chemotherapy regimens in the advanced setting.)
Patients must have previously received at least one systemic standard care (or effective salvage chemotherapy regimens) for metastatic or unresectable disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens)
Patients who received imatinib and 1 or 2 other TKIs as prior treatment regimens. Patients who experienced intolerance to prior therapies must have objective disease progression prior to enrollment onto BLU-285-1303 study.
Patients who have received more than 3 different prior TKI treatment regimens.
Patients must have had at least one prior chemotherapy regimen that includes pemetrexed and cisplatin or carboplatin; there is no limit to the number of prior chemotherapy regimens received
Part A patients who have received more than 3 prior cytoreductive chemotherapy regimens.
Patients must have had at least two prior chemotherapeutic or biologic (e.g. rituximab alone) regimens and not currently eligible for standard curative options; steroids alone and local radiation do not count as regimens
Patients previously treated with chemotherapy must have no more than two prior chemotherapy regimens for the treatment of metastatic prostate cancer
Patients must have received at least one prior chemotherapy regimen and up to any number of prior systemic regimens including chemotherapy and molecular targeted therapy other than PD1/ PDL1/ PDL2 inhibitors
Up to 3 prior chemotherapy regimens or metastatic disease
Received at least 3 prior chemotherapy-containing regimens.
Received fewer than 3 prior chemotherapy-containing regimens.
Subjects have received at least two standard chemotherapy regimens for which they would be considered eligible (at least one containing a 5-fluoropyrimidine), or systemic chemotherapy is not indicated in the setting of low volume metastatic disease
PRE-SCREENING: Must have had at least one and not more than two prior chemotherapy regimens for advanced disease (neoadjuvant chemotherapy would not be counted as a line of therapy)
Patients must have had at least one prior chemotherapy regimen that includes pemetrexed and cisplatin or carboplatin; there is no limit to the number of prior chemotherapy regimens received
Have had disease progression, be refractory or intolerant to no more than 2 prior systemic regimens.
Received 3 or more prior myelotoxic treatment regimens
Patients must have previously received systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
There is no limit on the number of prior treatment regimens
Patients receiving any other investigational agents and or more that two different chemotherapy regimens for treatment of metastatic disease
Patients with any prior chemotherapy regimens are eligible
There is no limit to the number of prior treatment regimens provided that performance status and life expectancy meet the criteria above
There is no limit to the number of prior systemic treatment regimens
Phase I: patients are eligible with any number of prior regimens regardless of what those regimens contained (i.e. prior bortezomib or combination gemcitabine and adriamycin is acceptable)
There is no limit on number of prior regimens
Patients must have previously received prior first line standard therapy (or effective salvage chemotherapy regimens) for their disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
Patients may be enrolled in the study regardless of prior chemotherapy regimens
Patients must have previously received prior first line standard therapy (or effective salvage chemotherapy regimens) for their disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
Patients must have previously received first line standard therapy (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
Received 3 or more prior myelotoxic treatment regimens
Chemotherapy refractory large cell and high grade NHL (i.e. progressive disease after > 2 salvage regimens)
Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens)
Has received 2-6 prior chemotherapy regimens including taxanes in advanced setting Additional Inclusion Criteria for Dose Expansion Part Only:
Must have received at least 2 prior regimens of standard chemotherapy for mCRC and must have been refractory to or failed (includes intolerance to) those regimens. Prior standard chemotherapy may not have included TAS-102 or regorafenib, but must have included agents as specified in the protocol.
Part 1 patients may have an unlimited number of prior therapy regimens
Patients are allowed (but not required) to have up to two lines of prior chemotherapy regimens for metastatic disease
Systemic chemotherapy washout period >= 7 days; for investigational dugs and monoclonal antibodies washout period >= 5 x drug half-life; there are no limitations on number of prior treatment regimens
Prior chemotherapy with 0-2 regimens is allowed
Participants who have received oxaliplatin during prior systemic chemotherapy regimens are eligible for enrollment in this protocol
Participants who have received oxaliplatin during prior systemic chemotherapy regimens are eligible for enrollment in this protocol
Must have failed at least 1 regimen for metastatic disease, and have been treated with up to 2 prior chemotherapy regimens\r\n* There is no limit on the number of total prior regimens
Patients must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment
Is ineligible or inappropriate for other treatment regimens known to have effective potential
Disease progression after 1 prior ALK inhibitor therapy other than crizotinib. Patients may have had any number of prior chemotherapy regimens in any disease setting.
Disease progression after 2 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting.
Disease progression after 3 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting. ROS1-positive NSCLC patients may be:
Patients Must have completed 3 or 4 previous chemotherapy regimens.
Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
Patients are allowed to receive any number of prior chemotherapy regimens for recurrent disease
At least one, but no more than three, prior chemotherapy regimens for MBC.
Received and experienced disease progression on, or following one or two prior chemotherapy regimens for advanced disease.
Group B any number of prior regimens.
Received 3 or more prior myelotoxic treatment regimens
Documentation of recurrent or progressive GBM following at least one (1) prior therapeutic regimen including upfront radiation and chemotherapy with temozolomide; up to three additional therapeutic regimens for disease progression prior to enrollment to the study is permitted
Patients will be ineligible if they have advanced myeloma refractory to salvage chemotherapy regimens
Patients must have received less than 3 prior chemotherapy regimens for progressive meningioma
No more than 4 prior chemotherapeutic regimens for metastatic disease
No more than three prior systemic chemotherapy regimens
Patients who have relapsed or are refractory to at least one prior chemotherapy regimen, and for whom no standard therapy exists; there is no limit to the number of prior chemotherapy regimens received
Any number of prior treatment regimens is allowed
> 2 prior chemotherapy regimens
Subject may have received ?2 prior regimens for the treatment of their metastatic disease.
Patients with breast cancer may have received neoadjuvant or adjuvant chemotherapy and up to two prior chemotherapy regimens for metastatic or locally recurrent disease; subjects with ovarian cancer may have had two regimens for advanced or persistent disease
Other chemotherapy regimens may have been administered between the time of progression on prior trastuzumab containing regimen and protocol therapy; no restriction on prior chemotherapy regimens for advanced stage disease
COHORT I: Patients must have received at least one and no more than two prior systemic therapy regimens; at least one of the regimens must have included pemetrexed and a platinum
Any number of prior chemotherapy regimens is allowed
Participants who have received more than two prior chemotherapy regimens for metastatic CRPC
More than two prior regimens for therapy of MM
There is no limit on the number of prior chemotherapy regimens allowed; any prior treatment (with the exception of lanreotide or octreotide) must be completed at least 4 weeks prior to initiation of treatment
More than 4 prior chemotherapy regimens; note: repeat use of regimens count as 1 prior regimen; switching front-line therapy regimens (for example, from intraperitoneal to intravenous therapy) for reasons other than progression will count as 1 prior therapy; bevacizumab and other ‘targeted’ agents will count in the total number of prior regimens; vaccine therapies will not count in the total of prior therapies
Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
Any number of prior regimens is allowed; prior investigational therapy is allowed
Relapsed after ? 2 prior chemotherapy- or immunotherapy-based regimens for indolent NHL, or refractory to 2 prior chemotherapy and/ or immunotherapy-based regimens.
Patients with transformed indolent lymphoma must have received at least 2 prior chemotherapy- and/or immunotherapy-based regimens
Patients that have been treated with > 3 prior chemotherapy regimens
Patients with up to 2 prior chemotherapy regimens are eligible
Receipt of no more than three prior chemotherapy regimens; monoclonal antibody therapy alone and involved field radiotherapy are not included in this number; prior use of ofatumumab is allowed if there has been no disease progression following that therapy (i.e. ofatumumab-based salvage regimens are allowed)
Have received at least three prior chemotherapy regimens and have relapsed disease confirmed by radiologic assessment
Any number of prior chemotherapy regimens is permitted
There is no limit on the number of prior treatment regimens
Patients with recurrent or progressive disease after one or more regimens of pre-radiation chemotherapy
Patients must have had at least one prior therapy to be eligible for either the first or second stage a) Patients are eligible with any number of prior regimens regardless of what those regimens contained (i.e. prior Bortezomib or combination gemcitabine and adriamycin is acceptable).
Women with TNBC who have received at least one but no more than two prior chemotherapy regimens for TNBC
Patients who have had more than 4 prior chemotherapy regimens
Prior chemotherapy regimens =< 1
Chemotherapy: no limit to prior therapies; however, patients with multiple chemotherapy regimens will be screened for lymphocyte proliferation at investigator’s discretion
No more than 2 prior chemotherapy regimens.
Patients may not have received more than 4 prior regimens of therapy
Must have received the following treatment for glioblastoma: •Prior treatment with radiotherapy and temozolomide; Note: A maximum of two prior chemotherapy/antibody regimens (including bevacizumab or other direct VEFG/VEGFR inhibitors) for recurrent disease are permitted.
PANCREATIC CANCER COHORT (COHORT 4 ONLY): Patients must have had at least one prior chemotherapy for advanced disease; there is no limit to the number of prior chemotherapy regimens received
Patients must have previously received at least one systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
Prior treatment with ? 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL
Radiographic progression during treatment with erlotinib; prior chemotherapy regimens are permitted
Patients should have received a minimum of one, and up to five prior chemotherapy regimens
Any number of prior systemic therapeutic regimens including chemotherapy, pathway inhibitors, biochemotherapy, investigational agents, and immunotherapies other than ipilimumab or bavituximab
Patients who have failed at least 1 systemic chemotherapy regimen for metastatic disease, but not more than 2 regimens
Evidence of progressive disease during or following 1 or 2 prior chemotherapy regimens
No more than 2 prior regimens are allowed
Patients must have progressed on or been intolerant to a fluoropyrimidine-based chemotherapy regimen; there is no limit on the number of prior treatment regimens permitted
Any number of prior treatment regimens are allowed
Subject previously treated with chemotherapy must have no more than two prior chemotherapy regimens for the treatment of metastatic prostate cancer
Patients may have an unlimited number of prior therapy regimens
Patient received at least 2 prior regimens for MM.
More than one prior chemotherapy regimens
No more than two prior chemotherapy regimens for metastatic disease
Have received more than 3 prior CTX regimens
No more than 3 prior chemotherapy regimens
=< 2 prior chemotherapeutic regimens
Those receiving alternate regimens and those with other disease types
Have received prior chemotherapy regimens within 4 weeks of Day 1;
Patients must also receive a full myeloablative preparative regimen (patients treated with either total body irradiation (TBI)-based or high-dose chemotherapy only regimens are eligible other than high-dose busulfan containing regimens or regimens that include anti-thymocyte globulin or other T cell depleting antibodies)
Patients that are receiving or have received chemotherapy regimens are allowed
Intolerance to at least 2 prior standard therapy regimens
Two or more prior chemotherapy regimens for advanced disease
Zero or one prior chemotherapy regimens for metastatic disease
At least 1, but no more than 5, prior treatment regimens for MCL
Patients must have received less than three prior chemotherapy regimens for progressive meningioma
At least ? 2 prior treatment regimens for the underlying malignancy