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

Study Overview

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

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).

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.

Metastatic Pancreatic Cancer

DRUG: IPI-926 plus gemcitabine
DRUG: Placebo plus gemcitabine

IPI-926-03

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-04-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-03-02
First Submitted that Met QC Criteria 2010-05-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-03-06
First Posted (ACTUAL) 2010-05-25	Results First Posted N/A	Last Verified 2017-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Arm 1 (Phase 2) IPI-926 in combination with gemcitabine	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_COMPARATOR: Arm 2 (Phase 2) Placebo in combination with gemcitabine	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 DRUG: 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

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Arm 1 (Phase 2)

IPI-926 in combination with gemcitabine

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_COMPARATOR: Arm 2 (Phase 2)

Placebo in combination with gemcitabine

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

DRUG: 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

Primary Outcome Measures	Measure Description	Time Frame
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
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 Outcome Measures	Measure Description	Time Frame
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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Robert Ross, MD, Infinity Pharmaceuticals, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Learn

Resources

Patients

Caregivers

Clinical Trial Record