NCT00739453

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 Dose Limiting Toxicities (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 Non-small Cell Lung Carcinoma (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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	OSI-906	administered orally
DRUG	erlotinib	administered orally

Timeline

• Start date: 2008-10-23
• Primary completion: 2012-03-03
• Completion: 2012-03-03
• First posted: 2008-08-21
• Last updated: 2024-11-20

Locations

4 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study