This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with select relapsed or refractory solid tumors.
TGR-1202 will be evaluated alone or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with adenocarcinoma of the pancreas, adenocarcinoma of the colon, rectum, gastric and GE junction cancer, and GI Stromal Tumor (GIST) who have relapsed from or are refractory to prior treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
TG Therapeutics Trial Site
Nashville, Tennessee, United States
Adverse events as a measure of safety and tolerability of TGR-1202 as a single agent and in combination in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Time frame: Up to 28 days after the last patient enrolled
Overall Response Rate
Overall response rate with TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
Time frame: Up to 1 year
Duration of Response
Duration of response with TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
Time frame: Up to 1 year
Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax).
This endpoint will measure the plasma PK profile of TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.
Time frame: At selected timepoints up through 6 months
Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax).
Time frame: At selected timepoints up through 6 months
Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC)
Time frame: At selected timepoints up through 6 months
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