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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Metastatic Pancreatic Cancer

In brief

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).

Key facts

Study ID

NCT01130142

Run by

Infinity Pharmaceuticals, Inc.

People needed

122

Starts

2010-04-01

Expected to finish

2012-05-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age
• Pathologically confirmed metastatic pancreatic adenocarcinoma
• At least 1 radiologically evaluable metastatic lesion (RECIST 1.1).
• ECOG 0 or 1
• Life expectancy ≥3 months.
• All women of child bearing potential, all sexually active male patients, and partners of patients must agree to use adequate methods of birth control
• Ability to adhere to the study visit schedule
• Voluntarily signed an informed consent form

You may not qualify if…

• Islet cell, acinar cell carcinoma, non-adenocarcinoma, (i.e., lymphoma, sarcoma), adenocarcinoma originated from biliary tree or cystadenocarcinoma
• Prior treatment with chemotherapy for pancreatic cancer.
• Known central nervous system metastases
• Inadequate hematologic function
• Inadequate hepatic function
• Inadequate renal function
• External (percutaneous) biliary drain
• History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
• Venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation not appropriately anticoagulated or have NCI CTCAE Grade 2 or greater bleeding episode in the 3 weeks prior to administration of IPI-926
• Concurrent administration of the medications or foods known to inhibit CYP3A activity to a clinically relevant degree
• Presence of active infection or systemic use of antibiotics within 72 hours of treatment
• Significant co-morbid condition or disease which in the judgment of the Investigator would place the patient at undue risk or interfere with the study.
• Known human immunodeficiency virus (HIV) positivity
• Known hypersensitivity to gemcitabine, IPI-926, or their excipients
• Pregnant or lactating women

Where it is running

• Arizona Clinical Research Center — Tucson, Arizona, United States
• University of California San Diego Medical Center — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Kaiser Permanente — Vallejo, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Kansas City Cancer Center — Overland Park, Kansas, United States
• Norton Health Care — Louisville, Kentucky, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Weill Cornell Medical Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Willamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Institute of Translational Oncology Research — Greenville, South Carolina, United States
• Texas Oncology- Bedford — Bedford, Texas, United States
• Texas Oncology, PA — Dallas, Texas, United States
• South Texas Oncology and Hematology — San Antonio, Texas, United States
• Tyler Cancer Center — Tyler, Texas, United States
• Virginia Oncology Associates — Newport News, Virginia, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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