A Phase 1 Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®)



Status:Archived
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:April 2008
End Date:December 2011

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A Phase I Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®) in Patients With Advanced Solid Tumors


Multicenter, open-label, phase 1, cohort dose escalation study to determine the MTD of
OSI-906 in combination with erlotinib


The study will open with Schedule 1 (S1), in which OSI-906 is administered on Days 1-3 every
7 days. Erlotinib will be administered daily starting on Day 2. A treatment period is
defined as 21 days.

Initiation of Schedule 2 (S2), in which OSI-906 is administered daily starting on Day 1 and
erlotinib is administered daily starting on Day 2, will occur after observation of
clinically significant related toxicity >/= grade 2 in any patient on S1 or after > 2 dose
levels in S1 have been examined without evidence of DLT.

Initiation of Schedule 3 (S3), in which OSI-906 is administered twice daily starting on Day
1 and erlotinib is administered daily starting on Day 2, will occur after observation of
clinically significant related toxicity >/= grade 2 in any patient on S2 or after > 2 dose
levels in S2 have been examined without evidence of DLT.

Once the phase 2 dose has been established for S3, 1 expansion cohort will be opened.

The Expansion Cohort will enroll approximately 30 evaluable patients with stage IIIB/IV
NSCLC. Patients in the NSCLC Expansion Cohort will be required to have either archival
tissue or fresh tumor tissue available at the start of study.


We found this trial at
3
sites
Boulder, Colorado 80309
(303) 492-1411
University of Colorado, Boulder As the flagship university of the state of Colorado, CU-Boulder is...
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Boulder, CO
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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Detroit, MI
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