Phase I Study of OSI-930 and Erlotinib in Cancer Tumors
This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors|
- Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Safety, evaluate pharmacodynamic relationships [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||July 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Drug: OSI-930 and erlotinib
OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity
Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib.
Patients may continue to receive OSI-930 and Erlotinib 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.
|United States, Florida|
|H Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|The Beatson West of Scotland Cancer Centre|
|Glasgow, United Kingdom, G12 0YN|