A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- Registration Number
- NCT01130142
- Lead Sponsor
- Infinity Pharmaceuticals, Inc.
- Brief 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).
- Detailed Description
IPI 926 is an inhibitor of the Hedgehog Pathway. IPI-926 in combination with gemcitabine may improve therapeutic outcomes in patients with pancreatic cancer. Infinity is conducting a Phase 1b/2 clinical trial to evaluate the safety and efficacy of IPI-926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 (Phase 2) Placebo plus gemcitabine Placebo in combination with gemcitabine Arm 2 (Phase 2) IPI-926 plus gemcitabine Placebo in combination with gemcitabine Arm 1 (Phase 2) IPI-926 plus gemcitabine IPI-926 in combination with gemcitabine
- Primary Outcome Measures
Name Time Method Evaluation of safety profile including MTD Once per week for 3 weeks of a 4 week cycle To determine the safety profile, including maximum tolerated dose, of IPI-926 plus gemcitabine in patients with previously untreated metastatic pancreatic cancer.
Overall survival comparison An average of 6 months * To compare the overall survival (OS) of patients with previously untreated metastatic pancreatic cancer treated with IPI-926 plus gemcitabine or placebo plus gemcitabine.
* To evaluate the safety of IPI-926 plus gemcitabine or placebo plus gemcitabine.
- Secondary Outcome Measures
Name Time Method Measurement of the maximum plasma concentration (Cmax) and area under the concentration versus time curve (AUC0-t) of IPI-926 and gemcitabine. During the 3rd week of the first 4 week cycle - To evalutate pharmacokinetics (PK) of IPI-926, gemcitabine, and their relevant metabolites.
Comparison of PFS, TTP and ORR An average of 6 months - To compare the progression free survival (PFS), time to progression (TTP) and overall response rate (ORR) of patients treated with IPI-926 plus gemcitabine or placebo plus gemcitabine.
Trial Locations
- Locations (28)
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
South Texas Oncology and Hematology
🇺🇸San Antonio, Texas, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Kaiser Permanente
🇺🇸Vallejo, California, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Norton Health Care
🇺🇸Louisville, Kentucky, United States
Kansas City Cancer Center
🇺🇸Overland Park, Kansas, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Institute of Translational Oncology Research
🇺🇸Greenville, South Carolina, United States
Texas Oncology, PA
🇺🇸Dallas, Texas, United States
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
Cancer Care Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Virginia Oncology Associates
🇺🇸Newport News, Virginia, United States
Texas Oncology- Bedford
🇺🇸Bedford, Texas, United States