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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02574663

Enrollment

Registered

2015-10-14

Start date

2015-09-11

Completion date

2018-08-31

Last updated

2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

DRUGTGR-1202

TGR-1202 oral daily dose

DRUGnab-paclitaxel + gemcitabine

IV infusion

DRUGOxaliplatin + Folinic acid + Fluorouracil

IV infusion

DRUGOxaliplatin + Folinic acid + Fluorouracil + Bevacizumab

IV Infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026