|Closed||Metastatic Pancreatic Cancer||Phase I/II||
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).
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.