Clinical trial NCT02574663: TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Colorectal Cancer
Rectal Cancer
Gastric Cancer
Esophageal Cancer
Gastrointestinal Stromal Tumor (GIST)
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: SCRI Development Innovations, LLC
First posted: 2015-10-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Up to 28 days after the last patient enrolled
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 1 year
measure: Duration of Response
timeFrame: Up to 1 year
measure: Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax).
timeFrame: At selected timepoints up through 6 months
measure: Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax).
timeFrame: At selected timepoints up through 6 months
measure: Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC)
timeFrame: At selected timepoints up through 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: TG Therapeutics Trial Site
state: Tennessee
Study officials:
affiliation: Sarah Cannon Research Instititue (SCRI)
name: Johanna Bendell, MD
role: STUDY_CHAIR
References: