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

Metastatic Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130142
• Other study ID #: IPI-926-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 21, 2010
• Last updated: March 2, 2017
• Start date: April 2010
• Est. completion date: May 2012

Study information

• Verified date: March 2017
• Source: Infinity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Cancer Care Manitoba	Winnipeg	Manitoba
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Texas Oncology- Bedford	Bedford	Texas
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Texas Oncology, PA	Dallas	Texas
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Institute of Translational Oncology Research	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Norton Health Care	Louisville	Kentucky
United States	Columbia University Medical Center	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Kansas City Cancer Center	Overland Park	Kansas
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of Rochester	Rochester	New York
United States	South Texas Oncology and Hematology	San Antonio	Texas
United States	University of California San Diego Medical Center	San Diego	California
United States	University of California San Francisco	San Francisco	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	Tyler Cancer Center	Tyler	Texas
United States	Kaiser Permanente	Vallejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Infinity Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of safety profile including MTD	To determine the safety profile, including maximum tolerated dose, of IPI-926 plus gemcitabine in patients with previously untreated metastatic pancreatic cancer.	Once per week for 3 weeks of a 4 week cycle
Primary	Overall survival comparison	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.	An average of 6 months
Secondary	Measurement of the maximum plasma concentration (Cmax) and area under the concentration versus time curve (AUC0-t) of IPI-926 and gemcitabine.	- To evalutate pharmacokinetics (PK) of IPI-926, gemcitabine, and their relevant metabolites.	During the 3rd week of the first 4 week cycle
Secondary	Comparison of PFS, TTP and ORR	- 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.	An average of 6 months