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
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
-
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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:
- 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
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
|
TGR-1202 oral daily dose
|
|
Experimental: TGR-1202 + nab-paclitaxel + gemcitabine
TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion
|
TGR-1202 oral daily dose
IV infusion
Other Names:
|
|
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)
|
TGR-1202 oral daily dose
IV infusion
Other Names:
|
|
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
|
TGR-1202 oral daily dose
IV Infusion
Other Names:
|
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
Collaborators
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
- Digestive System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Neoplasms, Connective Tissue
- Gastrointestinal Stromal Tumors
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Hematinics
- Gemcitabine
- Paclitaxel
- Fluorouracil
- Oxaliplatin
- Bevacizumab
- Leucovorin
- Levoleucovorin
- Albumin-Bound Paclitaxel
- Folic Acid
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.