NCT01567384

A Phase I Study of OSI-906 in Combination With Pemetrexed in Advanced Solid Tumor Malignancies

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to test the safety of an experimental drug called OSI-906 when combined with pemetrexed at different dose levels and to find out the optimal doses of the two drugs that can be given as a combination. Pemetrexed has been widely used for treatment of certain solid organ tumors and is effective and approved for use in treatment of lung cancer and mesothelioma.

Detailed description

OSI-906 is a new agent that inhibits the insulin-like growth factor receptor pathway. Targeting this pathway appears to be a promising strategy to treat cancer based on laboratory studies. The present study will test if this agent can be administered safely in combination with pemetrexed, a commonly used chemotherapeutic agent.

Conditions

• Cancer
• Neoplasms
• Tumors

Interventions

Type	Name	Description
DRUG	OSI-906 and Pemetrexed	Pemetrexed will be administered intravenously on day 1 of cycle 1 at a dose of 500 mg/m2 as a 10-minute infusion. Subsequent doses will be defined by tolerability. OSI-906 will be administered orally twice daily (12 hours apart) at approximately the same times each day on a continuous schedule, beginning on Day 0 of cycle 1.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-03-30
• Last updated: 2013-11-20

Locations

1 site across 1 country: United States