Phase I Dasatinib/Erlotinib in Recurrent Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT00444015
Phase
PHASE1
Status
Completed

Conditions

  • Non-Small-Cell Lung Carcinoma

Eligibility Criteria

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

Interventions

Study Details

This is a single site phase I dose escalation trial of the epidermal growth factor receptor inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with previously treated advanced stage (Stage IIIB/IV disease) Non-Small Cell Lung Cancer (NSCLC). The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets starting Day 9 for a 28-day cycle. If there are no Dose Limiting Toxicities (DLTs), dose escalation continues. The recommended phase II dose for this combined treatment will be defined and patients will be treated at the recommended phase II dose to confirm tolerability.

Key Dates

First listed
Mar 7, 2007
Start date
Mar 31, 2007
Status verified
Jun 2011
Primary completion
Aug 31, 2010
Completion
Aug 31, 2010

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation

Primary Outcome Measure

Number of Serious Adverse Events (SAEs) Reported [ Time Frame: 3 months per patient ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-

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By research site
H. Lee Moffitt Cancer Center & Research Institute· Tampa, FL

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