Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01130142
First received: April 21, 2010
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: IPI-926 plus gemcitabine
Drug: Placebo plus gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Evaluation of safety profile including MTD [ Time Frame: Once per week for 3 weeks of a 4 week cycle ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: An average of 6 months ] [ Designated as safety issue: Yes ]
    • 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:
  • Measurement of the maximum plasma concentration (Cmax) and area under the concentration versus time curve (AUC0-t) of IPI-926 and gemcitabine. [ Time Frame: During the 3rd week of the first 4 week cycle ] [ Designated as safety issue: No ]
    - To evalutate pharmacokinetics (PK) of IPI-926, gemcitabine, and their relevant metabolites.

  • Comparison of PFS, TTP and ORR [ Time Frame: An average of 6 months ] [ Designated as safety issue: No ]
    - 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.


Enrollment: 122
Study Start Date: April 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 (Phase 2)
IPI-926 in combination with gemcitabine
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
Other Names:
  • IPI-926
  • Hedgehog pathway inhibitor
  • Hedgehog
Placebo Comparator: Arm 2 (Phase 2)
Placebo in combination with gemcitabine
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
Other Names:
  • IPI-926
  • Hedgehog pathway inhibitor
  • Hedgehog
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
Other Names:
  • Gemcitabine
  • Hedgehog
  • Hedgehog pathway inhibitor
  • Gemzar

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130142

  Hide Study Locations
Locations
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85745
United States, California
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, 94503
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Kansas
Kansas City Cancer Center
Overland Park, Kansas, United States, 66210
United States, Kentucky
Norton Health Care
Louisville, Kentucky, United States, 40220
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10065
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14604
United States, Oregon
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States
United States, South Carolina
Institute of Translational Oncology Research
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Oncology- Bedford
Bedford, Texas, United States
Texas Oncology, PA
Dallas, Texas, United States, 75246
South Texas Oncology and Hematology
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
Study Director: Robert Ross, MD Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01130142     History of Changes
Other Study ID Numbers: IPI-926-03
Study First Received: April 21, 2010
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014