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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-11

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TGR-1202

TGR-1202 daily dose

Group Type EXPERIMENTAL

TGR-1202

Intervention Type DRUG

TGR-1202 oral daily dose

TGR-1202 + nab-paclitaxel + gemcitabine

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

Group Type EXPERIMENTAL

TGR-1202

Intervention Type DRUG

TGR-1202 oral daily dose

nab-paclitaxel + gemcitabine

Intervention Type DRUG

IV infusion

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)

Group Type EXPERIMENTAL

TGR-1202

Intervention Type DRUG

TGR-1202 oral daily dose

Oxaliplatin + Folinic acid + Fluorouracil

Intervention Type DRUG

IV infusion

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

Group Type EXPERIMENTAL

TGR-1202

Intervention Type DRUG

TGR-1202 oral daily dose

Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab

Intervention Type DRUG

IV Infusion

Interventions

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TGR-1202

TGR-1202 oral daily dose

Intervention Type DRUG

nab-paclitaxel + gemcitabine

IV infusion

Intervention Type DRUG

Oxaliplatin + Folinic acid + Fluorouracil

IV infusion

Intervention Type DRUG

Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab

IV Infusion

Intervention Type DRUG

Other Intervention Names

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Abraxane (nab-paclitaxel) + Gemzar (gemcitabine) Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) + Avastin (Bevacizumab)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No