Colorectal Cancer Clinical Trial
Official title:
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
Verified date | October 2019 |
Source | TG Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed: 1. adenocarcinoma of the pancreas (pancreatic cancer) 2. adenocarcinoma of the colon or rectum (colorectal cancer) 3. adenocarcinoma of the gastric (gastric cancer) 4. esophageal cancer 5. gastrointestinal stromal tumor (GIST) - Relapsed or refractory disease - Measurable lesion by RECIST 1.1 Exclusion Criteria: - Known Hepatitis B, C or HIV infection - Previous therapy with any drug that inhibits the PI3K pathway - Anti-tumor therapy within 21 days of study Day 1 |
Country | Name | City | State |
---|---|---|---|
United States | TG Therapeutics Trial Site | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
TG Therapeutics, Inc. | SCRI Development Innovations, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 28 days after the last patient enrolled | |
Secondary | 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. | Up to 1 year | |
Secondary | 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. | Up to 1 year | |
Secondary | 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. | At selected timepoints up through 6 months | |
Secondary | Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax). | At selected timepoints up through 6 months | ||
Secondary | Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC) | At selected timepoints up through 6 months |
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