Know Cancer

or
forgot password

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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Pancreatic Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Evaluation of safety profile including MTD

Outcome Description:

To determine the safety profile, including maximum tolerated dose, of IPI-926 plus gemcitabine in patients with previously untreated metastatic pancreatic cancer.

Outcome Time Frame:

Once per week for 3 weeks of a 4 week cycle

Safety Issue:

Yes

Principal Investigator

Robert Ross, MD

Investigator Role:

Study Director

Investigator Affiliation:

Infinity Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

IPI-926-03

NCT ID:

NCT01130142

Start Date:

April 2010

Completion Date:

May 2012

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rhode Island HospitalProvidence, Rhode Island  02903
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Hackensack University Medical CenterHackensack, New Jersey  07601
Virginia Oncology AssociatesNewport News, Virginia  23606
South Texas Oncology and HematologySan Antonio, Texas  78229
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Seattle Cancer Care AllianceSeattle, Washington  98109
Arizona Clinical Research CenterTucson, Arizona  85712
Tyler Cancer CenterTyler, Texas  75702
University of California San FranciscoSan Francisco, California  941104206
University of RochesterRochester, New York  14642
Weill Cornell Medical CenterNew York, New York  10021
Providence Portland Medical CenterPortland, Oregon  97213-3635
Kaiser PermanenteSacramento, California  
Texas Oncology, PADallas, Texas  75246-2006
Columbia University Medical CenterNew York, New York  10032
Kansas City Cancer CenterKansas City, Kansas  66112
Willamette Valley Cancer Institute and Research CenterSpringfield, Oregon  97477
Institute of Translational Oncology ResearchGreenville, South Carolina  29605
University of California San Diego Medical CenterSan Diego, California  92103-8409
Norton Health CareLouisville, Kentucky  40220
Texas Oncology- BedfordBedford, Texas