Phase I Study of OSI-930 and Erlotinib in Cancer Tumors

Part of paid clinical trials in Tampa, Florida.

Sponsor
Astellas Pharma Inc
Study ID
NCT00603356
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • OSI-930 and erlotinib — DRUG
    OSI-930 administered daily in combination with Erlotinib at increasing doses until disease progression or unacceptable toxicity

Study Details

This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.

Key Dates

First listed
Jan 29, 2008
Start date
Nov 30, 2007
Status verified
Sep 2011
Primary completion
Apr 30, 2010
Completion
Jul 31, 2010

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Dose Escalation

Primary Outcome Measure

Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

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