TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors

Sponsor

TG Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02574663

Collaborator

SCRI Development Innovations, LLC (Other)

Enrollment

Location

Arms

34.7

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Colorectal Cancer Rectal Cancer Gastric Cancer Esophageal Cancer Gastrointestinal Stromal Tumor (GIST)	Drug: TGR-1202 Drug: nab-paclitaxel + gemcitabine Drug: Oxaliplatin + Folinic acid + Fluorouracil Drug: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 11, 2015

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TGR-1202 TGR-1202 daily dose	Drug: TGR-1202 TGR-1202 oral daily dose
Experimental: TGR-1202 + nab-paclitaxel + gemcitabine TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion	Drug: TGR-1202 TGR-1202 oral daily dose Drug: nab-paclitaxel + gemcitabine IV infusion Other Names: Abraxane (nab-paclitaxel) + Gemzar (gemcitabine)
Experimental: TGR-1202 + FOLFOX 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 TGR-1202 oral daily dose Drug: Oxaliplatin + Folinic acid + Fluorouracil IV infusion Other Names: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil)
Experimental: TGR-1202 + FOLFOX + Bevacizumab 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 TGR-1202 oral daily dose Drug: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab IV Infusion Other Names: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) + Avastin (Bevacizumab)

Outcome Measures

Primary Outcome Measures

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. [Up to 28 days after the last patient enrolled]
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.

Secondary Outcome Measures

Overall Response Rate [Up to 1 year]
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.
Duration of Response [Up to 1 year]
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.
Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax). [At selected timepoints up through 6 months]
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.
Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax). [At selected timepoints up through 6 months]
Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC) [At selected timepoints up through 6 months]