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

Phase 1/Phase 2
18 Years
Not Enrolling
Metastatic Pancreatic Cancer

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Evaluation of safety profile including MTD

Outcome Description:

To determine the safety profile, including maximum tolerated dose, of IPI-926 plus gemcitabine in patients with previously untreated metastatic pancreatic cancer.

Outcome Time Frame:

Once per week for 3 weeks of a 4 week cycle

Safety Issue:


Principal Investigator

Robert Ross, MD

Investigator Role:

Study Director

Investigator Affiliation:

Infinity Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2010

Completion Date:

May 2012

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Pancreatic Neoplasms



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