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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574663
• Other study ID #: TGR-1202-102 (RM-404)
• Status: Completed
• Phase: Phase 1
• Start date: September 11, 2015
• Est. completion date: August 2018

Study information

• Verified date: October 2019
• Source: TG Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Esophageal Cancer
• Gastric Cancer
• Gastrointestinal Stromal Tumor (GIST)
• Gastrointestinal Stromal Tumors
• Pancreatic Cancer
• Rectal Cancer

Intervention

Drug:
• TGR-1202
TGR-1202 oral daily dose
• nab-paclitaxel + gemcitabine
IV infusion
• Oxaliplatin + Folinic acid + Fluorouracil
IV infusion
• Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab
IV Infusion

Locations

Country	Name	City	State
United States	TG Therapeutics Trial Site	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
TG Therapeutics, Inc.	SCRI Development Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

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