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NCT Number: NCT02574663

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.

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Key information

Conditions

Pancreatic Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumor (GIST) Gastrointestinal Stromal Tumors Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Pancreatic Diseases Pancreatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TG Therapeutics Trial Site

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed:
  • adenocarcinoma of the pancreas (pancreatic cancer)
  • adenocarcinoma of the colon or rectum (colorectal cancer)
  • adenocarcinoma of the gastric (gastric cancer)
  • esophageal cancer
  • 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

Treatment and study plan

TGR-1202

Drug

TGR-1202 oral daily dose

Nab-paclitaxel + Gemcitabine

Drug

IV infusion

Other names: Abraxane (nab-paclitaxel) + Gemzar (gemcitabine)

Oxaliplatin + Folinic acid + Fluorouracil

Drug

IV infusion

Other names: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil)

Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab

Drug

IV Infusion

Other names: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) + Avastin (Bevacizumab)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax).

    Time frame: At selected timepoints up through 6 months

  5. Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC)

    Time frame: At selected timepoints up through 6 months

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Collaborators

  • SCRI Development Innovations, LLC

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 14, 2015
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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