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

October 1, 2019 updated by: TG Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • TG Therapeutics Trial Site

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TGR-1202
TGR-1202 daily dose
Drug: TGR-1202
TGR-1202 oral daily dose
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
Other Names:
  • Abraxane (nab-paclitaxel) + Gemzar (gemcitabine)
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
Other Names:
  • Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil)
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
Other Names:
  • Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) + Avastin (Bevacizumab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 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.
Up to 28 days after the last patient enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: 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.
Up to 1 year
Duration of Response
Time Frame: 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.
Up to 1 year
Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax).
Time Frame: 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.
At selected timepoints up through 6 months
Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax).
Time Frame: At selected timepoints up through 6 months
At selected timepoints up through 6 months
Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC)
Time Frame: At selected timepoints up through 6 months
At selected timepoints up through 6 months

Collaborators and Investigators

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

Sponsor

TG Therapeutics, Inc.

Collaborators

SCRI Development Innovations, LLC

Investigators

  • Study Chair: Johanna Bendell, MD, Sarah Cannon Research Instititue (SCRI)

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 Major Dates

Study Start (Actual)

September 11, 2015

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGR-1202-102 (RM-404)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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