TGR-1202 Alone And In Combination With Either Nab-paclitaxel + Gemcitabine Or With FOLFOX In Patients With Select Relapsed Or Refractory Solid Tumors

Study Overview

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

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.

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.

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

DRUG: TGR-1202
DRUG: nab-paclitaxel + gemcitabine
DRUG: Oxaliplatin + Folinic acid + Fluorouracil
DRUG: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab

TGR-1202-102 (RM-404)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-10-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-10-01
First Submitted that Met QC Criteria 2015-10-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-10-02
First Posted (ACTUAL) 2015-10-14	Results First Posted N/A	Last Verified 2019-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: TGR-1202 TGR-1202 daily dose	DRUG: TGR-1202 TGR-1202 oral daily dose DRUG: nab-paclitaxel + gemcitabine IV infusion DRUG: Oxaliplatin + Folinic acid + Fluorouracil IV infusion DRUG: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab IV Infusion
EXPERIMENTAL: TGR-1202 + nab-paclitaxel + gemcitabine TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion	DRUG: TGR-1202 TGR-1202 oral daily dose DRUG: nab-paclitaxel + gemcitabine IV infusion
EXPERIMENTAL: 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)	DRUG: TGR-1202 TGR-1202 oral daily dose DRUG: Oxaliplatin + Folinic acid + Fluorouracil IV infusion DRUG: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab IV Infusion
EXPERIMENTAL: 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	DRUG: TGR-1202 TGR-1202 oral daily dose DRUG: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab IV Infusion

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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
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
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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed:

Relapsed or refractory disease
Measurable lesion by RECIST 1.1

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

SCRI Development Innovations, LLC

Investigators

STUDY_CHAIR: Johanna Bendell, MD, Sarah Cannon Research Instititue (SCRI)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record