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

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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.

Study Description
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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).


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
Study Start Date : April 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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Arms and Interventions
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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:
  • Gemcitabine
  • Hedgehog
  • Hedgehog pathway inhibitor
  • Gemzar


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130142


  Show 28 Study Locations
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
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Study Director: Robert Ross, MD Infinity Pharmaceuticals, Inc.
More Information
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Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01130142     History of Changes
Other Study ID Numbers: IPI-926-03
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Veratrum Alkaloids
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antihypertensive Agents