Previous treatment with regorafenib AND TAS-102 (this applies to phase II only; if patients have previously received either regorafenib OR TAS-102, they must be able to receive the alternate regimen if randomized to the standard of care arm)
Prior treatment with regorafenib
Prior use of regorafenib
Prior use of regorafenib
Patients who have received prior treatment with avapritinib or regorafenib.
Received at least one line of therapy with sorafenib and/or regorafenib with evidence of disease progression clinically or radiographically as deemed by investigator, or refused therapy with sorafenib and/or regorafenib; no more than two lines of prior therapy are allowed
Up to 5 of the 15 patients will be allowed to have had other approved or investigational drugs after prior progression of regorafenib monotherapy; (all patients enrolled in this trial must have had prior progression on regorafenib therapy); this may include TAS102, off-label therapy that may have been prescribed based on tumor genomic profiling or any investigational agents on a clinical trial
No more than grade 2 toxicity with last previous cycle of regorafenib mono therapy
Patients must have progressed on imatinib, sunitinib, and regorafenib or have documented intolerance to any of these treatments.
REGORAFENIB INCLUSION CRITERIA: ECOG performance status 0-1
REGORAFENIB INCLUSION CRITERIA: Life expectancy >= 12 weeks
REGORAFENIB INCLUSION CRITERIA: Platelets >= 100,000/mm^3
REGORAFENIB INCLUSION CRITERIA: Hemoglobin >= 9 g/dL
REGORAFENIB EXCLUSION CRITERIA: Uveal melanoma
REGORAFENIB EXCLUSION CRITERIA: Previous assignment to treatment during this study; patients permanently withdrawn from study participation will not be allowed to reenter
REGORAFENIB EXCLUSION CRITERIA: Previously identified allergy or hypersensitivity to components of regorafenib formulation
REGORAFENIB EXCLUSION CRITERIA: Diagnosis of concurrent malignancy or previous malignancy within 3 years before study drug administration (exceptions are superficial skin cancers, or any in situ cancers deemed curatively treated and without evidence of disease for more than 3 years before regorafenib treatment)
REGORAFENIB EXCLUSION CRITERIA: Any hemorrhage or bleeding event >= grade 3 within 4 weeks prior to start of regorafenib
REGORAFENIB EXCLUSION CRITERIA: Major surgical procedure or significant traumatic injury within 28 days before start of regorafenib
Advanced solid tumor that has progressed during or after treatment with approved therapies or for which there is no standard effective therapy available\r\n* Note: patients with solid tumors for which regorafenib would be considered a standard treatment are eligible as long as regorafenib has not been previously administered
Previous therapy with regorafenib
Prior systemic therapy for HCC; prior exposure to regorafenib.
Prior treatment with TAS-102 or regorafenib
Prior use of regorafenib
Prior treatment with regorafenib
Received FOLFOX within 6 weeks before starting regorafenib
Prior use of regorafenib.
Prior regorafenib use with disease progression (expanded cohort only)
Prior failure to tolerate regorafenib at 120 mg/day
Prior treatment with regorafenib
Histologically confirmed metastatic and/or unresectable GIST; patients must demonstrate prior failure to at least imatinib, sunitinib and regorafenib (4th line and beyond); any number of previous therapies for GIST is allowed; failure of imatinib is defined as either prior intolerance to imatinib therapy or prior progression of disease on imatinib in the metastatic setting or progression during adjuvant imatinib, or within 3 months of completing adjuvant imatinib; failure of sunitinib and regorafenib is defined only as prior progression of disease on sunitinib or on regorafenib as assessed by the investigator
Patients with intolerance to sunitinib and/or regorafenib
Prior use of regorafenib or other anti VEGF drugs
Prior use of regorafenib
Subject has previously received regorafenib;
For patients to be treated with a regimen containing regorafenib:
Known hypersensitivity to regorafenib
Prior treatment with regorafenib
Prior treatment with regorafenib.
Prior use of regorafenib; subjects permanently withdrawn from study participation will not be allowed to re-enter study
Prior use of regorafenib
Prior use of regorafenib
Prior treatment with refametinib or regorafenib.
Prior treatment with regorafenib.
Pretreatment with regorafenib.
Subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country)
Prior treatment with Regorafenib
Prior use of regorafenib
Prior use of regorafenib
Patients with a clinical diagnosis of cancer that are within +/- 3 days of initiating treatment with sorafenib, sunitinib, or regorafenib.\r\n* Note: patients treated with a combination regimen that includes sorafenib, regorafenib, or sunitinib are eligible.
Patients may not be receiving any other investigational agents.\r\n* Note: it is acceptable to be on combination therapy including either sorafenib, regorafenib, and/or sunitinib.
Advanced cancer patient scheduled to receive regorafenib
Prior use of regorafenib