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

March 2, 2017 updated by: Infinity Pharmaceuticals, Inc.

A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Gemzar
  • Gemcitabine
  • Hedgehog pathway inhibitor
  • Hedgehog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of safety profile including MTD
Time Frame: 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.
Once per week for 3 weeks of a 4 week cycle
Overall survival comparison
Time Frame: 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.
An average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
- To evalutate pharmacokinetics (PK) of IPI-926, gemcitabine, and their relevant metabolites.
During the 3rd week of the first 4 week cycle
Comparison of PFS, TTP and ORR
Time Frame: 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.
An average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infinity Pharmaceuticals, Inc.

Investigators

  • Study Director: Robert Ross, MD, Infinity Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimate)

May 25, 2010

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-926-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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