A Phase 1 interventional study of TGR-1202 and nab-paclitaxel + gemcitabine in Pancreatic Cancer, Colorectal Cancer and Rectal Cancer, sponsored by TG Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by TG Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
333 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.
This study's enrollment of 66 is above the median of 50 across 243 interventional studies indexed under Gastrointestinal Stromal Tumors.
Browse Gastrointestinal Stromal Tumors studies →TG Therapeutics, Inc. is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Histologically confirmed:
Exclusion Criteria:
TGR-1202 daily dose
Drug: TGR-1202
TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion
Drug: TGR-1202 · Drug: nab-paclitaxel + gemcitabine
TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen)
Drug: TGR-1202 · Drug: Oxaliplatin + Folinic acid + Fluorouracil
TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) + bevacizumab IV infusion
Drug: TGR-1202 · Drug: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab
TGR-1202 oral daily dose
IV infusion
Also known as: Abraxane (nab-paclitaxel) + Gemzar (gemcitabine)
IV infusion
Also known as: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil)
IV Infusion
Also known as: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) + Avastin (Bevacizumab)
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
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gastrointestinal Stromal Tumors→
TG Therapeutics, Inc.