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A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT01130142•Infinity Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (28)

Arizona Clinical Research Center

Tucson, Arizona, United States

University of California San Diego Medical Center

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Kaiser Permanente

Vallejo, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Kansas City Cancer Center

Overland Park, Kansas, United States

Norton Health Care

Louisville, Kentucky, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Key Dates

Start Date

April 1, 2010

Primary Completion Date

May 1, 2012

Completion Date

May 1, 2012

Last Updated

March 6, 2017

Enrollment

122

ACTUAL participants

Conditions

Metastatic Pancreatic Cancer

Interventions

IPI-926 plus gemcitabine

DRUG

Placebo plus gemcitabine

DRUG

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

NCT07409272

Pancreatic CancerMetastatic Pancreatic Cancer+1 more

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RECRUITINGPHASE2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

NCT05065801

Metastatic Pancreatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer