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

TG Therapeutics

Status and phase: Completed; Phase 1

Conditions: Esophageal Cancer; Gastric Cancer; Gastrointestinal Stromal Tumor (GIST); Rectal Cancer; Colorectal Cancer; Pancreatic Cancer

Treatments: Drug: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab; Drug: Oxaliplatin + Folinic acid + Fluorouracil; Drug: TGR-1202; Drug: nab-paclitaxel + gemcitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02574663

TGR-1202-102 (RM-404)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 4 patient groups

TGR-1202

Experimental group

Description:

TGR-1202 daily dose

Treatment:

Drug: TGR-1202

TGR-1202 + nab-paclitaxel + gemcitabine

Experimental group

Description:

TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion

Treatment:

Drug: nab-paclitaxel + gemcitabine

Drug: TGR-1202

TGR-1202 + FOLFOX

Experimental group

Description:

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)

Treatment:

Drug: TGR-1202

Drug: Oxaliplatin + Folinic acid + Fluorouracil

TGR-1202 + FOLFOX + Bevacizumab

Experimental group

Description:

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

Treatment:

Drug: TGR-1202

Drug: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab