A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
NCT ID: NCT01130142
Last Updated: 2017-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
122 participants
INTERVENTIONAL
2010-04-30
2012-05-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 (Phase 2)
IPI-926 in combination with gemcitabine
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
Arm 2 (Phase 2)
Placebo in combination with gemcitabine
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
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Infinity Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Ross, MD
Role: STUDY_DIRECTOR
Infinity Pharmaceuticals, Inc.
Locations
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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
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Countries
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References
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Kochetkova M, Samuel MS. Differentiation of the tumor microenvironment: are CAFs the Organizer? Trends Cell Biol. 2022 Apr;32(4):285-294. doi: 10.1016/j.tcb.2021.11.008. Epub 2021 Dec 9.
Other Identifiers
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IPI-926-03
Identifier Type: -
Identifier Source: org_study_id
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