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A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer

NCT01130142 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2017-03-06

No results posted yet for this study

Summary

Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2 portion will commence.

Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there is no option for patients receiving placebo to cross-over to IPI-926).

Conditions

Interventions

DRUG

IPI-926 plus gemcitabine

Daily IPI-926 (oral) at 160 mg plus gemcitabine (infusion) at 1000 mg/m2 once weekly for 3 weeks of a 28 day cycle

DRUG

Placebo plus gemcitabine

Daily Oral placebo/IPI-926 160 mg plus gemcitabine infusion at 1000 mg/m2 once every 3 weeks in a 28 day cycle

Sponsors & Collaborators

  • Infinity Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Ross, MD · Infinity Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01130142 on ClinicalTrials.gov