A Phase I Dose Escalation Study of Daily Oral OSI-930 in Patients With Advanced Solid Tumors
Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated
dose on both once daily (QD) and twice daily (BID) schedules.
Patients may continue to receive OSI-930 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of OSI-930
United States: Food and Drug Administration
|University of Colorado Cancer Center||Denver, Colorado 80262|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|