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

April 21, 2010
June 13, 2013
April 2010
May 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01130142 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
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).

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Metastatic Pancreatic Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01130142
IPI-926-03
Yes
Infinity Pharmaceuticals, Inc.
Infinity Pharmaceuticals, Inc.
Not Provided
Study Director: Robert Ross, MD Infinity Pharmaceuticals, Inc.
Infinity Pharmaceuticals, Inc.
June 2013

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