Clinical trial NCT01130142: A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
Official title: A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Infinity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-25
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Evaluation of safety profile including MTD
timeFrame: Once per week for 3 weeks of a 4 week cycle
measure: Overall survival comparison
timeFrame: An average of 6 months
Secondary outcomes:
measure: Measurement of the maximum plasma concentration (Cmax) and area under the concentration versus time curve (AUC0-t) of IPI-926 and gemcitabine.
timeFrame: During the 3rd week of the first 4 week cycle
measure: Comparison of PFS, TTP and ORR
timeFrame: An average of 6 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Overland Park
country: United States
facility: Kansas City Cancer Center
state: Kansas
city: Louisville
country: United States
facility: Norton Health Care
state: Kentucky
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Institute of Translational Oncology Research
state: South Carolina
city: Bedford
country: United States
facility: Texas Oncology- Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Infinity Pharmaceuticals, Inc.
name: Robert Ross, MD
role: STUDY_DIRECTOR
References:
citation: Kochetkova M, Samuel MS. Differentiation of the tumor microenvironment: are CAFs the Organizer? Trends Cell Biol. 2022 Apr;32(4):285-294. doi: 10.1016/j.tcb.2021.11.008. Epub 2021 Dec 9.