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
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TG Therapeutics, Inc.
• Collaborator: SCRI Development Innovations, LLC
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Fluorouracil; Folic Acid; Gemcitabine; Leucovorin; Levoleucovorin; Oxaliplatin; Paclitaxel

Criteria

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