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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Astellas Pharma Inc
Study ID
NCT00739453
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OSI-906 — DRUG
    administered orally
  • erlotinib — DRUG
    administered orally

Study Details

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

Key Dates

First listed
Aug 21, 2008
Start date
Oct 23, 2008
Status verified
Nov 2024
Primary completion
Mar 3, 2012
Completion
Mar 3, 2012

Study Design

Enrollment
95 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Schedule 1
    OSI-906 is administered on Days 1-3 every 7 days. Erlotinib will be administered daily starting on Day 2 of the initial treatment period and on Day 1-21 for all remaining treatment periods.
  • Experimental: Schedule 2
    OSI-906 is administered daily starting on Day 1 and erlotinib is administered daily starting on Day 2 of the initial treatment period and on Day 1-21 for all remaining treatment periods.
  • Experimental: Schedule 3
    OSI-906 is administered continuously twice daily starting on Day 1 and erlotinib is administered daily starting on Day 2. The NSCLC expansion cohort will follow Schedule 3 with the exception that erlotinib is administered daily starting on Day 8.

Primary Outcome Measure

Determine the maximum tolerated dose (MTD) and recommended phase 2 dose of OSI-906 and erlotinib [ Time Frame: 21 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado Health Science CenterAuroraColorado80045-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
Hudson-Webber Cancer Research Center, Karmanos Cancer InstituteDetroitMichigan48201-

Find similar trials in Aurora, CO

By research site
University of Colorado Health Science Center· Aurora, COJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDHudson-Webber Cancer Research Center, Karmanos Cancer Institute· Detroit, MI

Related Studies