Phase 1 Study of Intermittent OSI-906 Dosing

Phase 1 Study of Intermittent OSI-906 Dosing

Solid Tumors

Ongoing, but not recruiting

1

Start Date 12/01/2006

Age of Trial (yrs) 17.4

Gleevec-resistant

IGF1R inhibitor

Block related tumor signal paths

GIST not specified. GIST patient enrollment unknown.

OSI-906-102

OSI Pharmaceuticals

OSIP Medical Information 800.572.1932 ext 7821 medical-information@osip.com

Oral

Multicenter, open-label, phase 1, cohort dose escalation. The study will open with S1 (OSI-906 QD Days 1-3 every 14 days). S2 (OSI-906 QD Days 1-5 every 14 days) will be initiated following observation of clinically significant related toxicity >/= grade 2 in S1 or after a review of preliminary safety and PK data from >/= 6 dose levels in S1 indicate that toxicity is acceptable and potential improvement in exposure may be achieved by an increased number of dosing days. S3 (OSI-906 QD Days 1-7 every 14 days) will occur upon observation of clinically significant related toxicity >/= grade 2 in S2 or after >/= 1 dose level in S2 has been examined.
In each schedule, a single dose will be administered on each of the specified days followed by a drug-free period through to Day 14. A treatment period is defined as 14 days. Patients may continue to receive OSI-906 until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.