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
1 other identifier
interventional
122
2 countries
28
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2010
Typical duration for phase_1
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMarch 6, 2017
March 1, 2017
2.1 years
April 21, 2010
March 2, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Measurement of the maximum plasma concentration (Cmax) and area under the concentration versus time curve (AUC0-t) of IPI-926 and gemcitabine.
During the 3rd week of the first 4 week cycle
Comparison of PFS, TTP and ORR
An average of 6 months
Study Arms (2)
Arm 1 (Phase 2)
ACTIVE COMPARATORIPI-926 in combination with gemcitabine
Arm 2 (Phase 2)
PLACEBO COMPARATORPlacebo in combination with gemcitabine
Interventions
Daily IPI-926 (oral) at 160 mg plus gemcitabine (infusion) at 1000 mg/m2 once weekly for 3 weeks of a 28 day cycle
Daily Oral placebo/IPI-926 160 mg plus gemcitabine infusion at 1000 mg/m2 once every 3 weeks in a 28 day cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Arizona Clinical Research Center
Tucson, Arizona, 85745, 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, 94503, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Kansas City Cancer Center
Overland Park, Kansas, 66210, United States
Norton Health Care
Louisville, Kentucky, 40220, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Medical Center
New York, New York, 10032, United States
Weill Cornell Medical Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14604, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Institute of Translational Oncology Research
Greenville, South Carolina, 29605, United States
Texas Oncology- Bedford
Bedford, Texas, United States
Texas Oncology, PA
Dallas, Texas, 75246, United States
South Texas Oncology and Hematology
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Cancer Care Manitoba
Winnipeg, Manitoba, R2H 2A6, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Related Publications (1)
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.
PMID: 34895986DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Ross, MD
Infinity Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2010
First Posted
May 25, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
March 6, 2017
Record last verified: 2017-03