NCT01600807

OSI-906 With Gemcitabine and Erlotinib for Metastatic Ductal Adenocarcinoma of the Pancreas

Phase I/II Trial of OSI-906 in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Ductal Adenocarcinoma of the Pancreas

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been used in other research studies and information from those suggests that OSI-906 may help block cell receptors involved in tumor growth. Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this research study, the investigators are looking for the highest dose of OSI-906 that can be given safely in combination with gemcitabine and erlotinib. This dose will then be given together with gemcitabine and erlotinib to a further group of patients with pancreatic cancer.

Detailed description

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.

Conditions

• Pancreatic Cancer, Metastatic

Interventions

Type	Name	Description
DRUG	Gemcitabine, Erlotinib, OSI-906	Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD, OSI-906 dose to be determined BID
DRUG	Gemcitabine, Erlotinib	Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD

Timeline

• First posted: 2012-05-17
• Last updated: 2013-06-26

Locations

2 sites across 1 country: United States