Trials / Completed
CompletedNCT02574663
TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Pancreatic Cancer
- Colorectal Cancer
- Rectal Cancer
- Gastric Cancer
- Esophageal Cancer
- Gastrointestinal Stromal Tumor (GIST)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TGR-1202 | TGR-1202 oral daily dose |
| DRUG | nab-paclitaxel + gemcitabine | IV infusion |
| DRUG | Oxaliplatin + Folinic acid + Fluorouracil | IV infusion |
| DRUG | Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab | IV Infusion |
Timeline
- Start date
- 2015-09-11
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2015-10-14
- Last updated
- 2019-10-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02574663. Inclusion in this directory is not an endorsement.