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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01130142
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 21, 2010
First Posted Date  ICMJE May 25, 2010
Last Update Posted Date March 6, 2017
Study Start Date  ICMJE April 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2010)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2010)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
Official Title  ICMJE A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm 1 (Phase 2)
    IPI-926 in combination with gemcitabine
    Intervention: Drug: IPI-926 plus gemcitabine
  • Placebo Comparator: Arm 2 (Phase 2)
    Placebo in combination with gemcitabine
    Interventions:
    • Drug: IPI-926 plus gemcitabine
    • Drug: Placebo plus gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2012)
122
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2010)
130
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01130142
Other Study ID Numbers  ICMJE IPI-926-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Infinity Pharmaceuticals, Inc.
Study Sponsor  ICMJE Infinity Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Ross, MD Infinity Pharmaceuticals, Inc.
PRS Account Infinity Pharmaceuticals, Inc.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP