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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.
• Treatments: Gemcitabine; Veratrum Alkaloids

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