TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
NCT02574663 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2019-10-02
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.
Conditions
- Pancreatic Cancer
- Colorectal Cancer
- Rectal Cancer
- Gastric Cancer
- Esophageal Cancer
- Gastrointestinal Stromal Tumor (GIST)
Interventions
- 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
Sponsors & Collaborators
-
SCRI Development Innovations, LLC
collaborator OTHER -
TG Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Johanna Bendell, MD · Sarah Cannon Research Instititue (SCRI)
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-11
- Primary Completion
- 2018-08-31
- Completion
- 2018-08-31
Countries
- United States
Study Locations
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