Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas
This study will be conducted in two parts: a phase I study and a phase II study. In both
instances, a treatment cycle is 28 days (4 weeks). Subjects will take OSI-906 by mouth,
twice a day, every day. Subjects will receive gemcitabine through an IV in clinic over 30
minutes on days 1, 8 and 15 of each 28-day cycle. Subjects will take erlotinib by mouth,
once a day, every day.
At every visit subjects will have a physical exam and blood tests. An EKG will be done on
days 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. A CT scan will be done
every 2 cycles (8 weeks).
Subjects will complete a daily drug diary and perform glucose monitoring (finger stick) once
daily at home.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with adverse events as a measure of safety and tolerability
Phase I study to assess the safety, tolerability and maximally tolerated dose (MTD) of OSI-906 administered in combination with gemcitabine and erlotinib is patients with metastatic pancreatic ductal adenocarcinoma
Brian Wolpin, MD, MPH
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|