Phase I Study of Lapatinib (GW572016) in Combination With Weekly Ixabepilone (BMS 247550) in Advanced Solid Tumors
OBJECTIVES:
Primary
- To evaluate the safety and feasibility of lapatinib ditosylate in combination with
ixabepilone in patients with advanced solid tumors.
Secondary
- To determine the maximum-tolerated dose of this regimen in these patients.
- To assess, preliminarily, the efficacy of this regimen in these patients.
- To perform laboratory correlative studies on tissue and blood specimens from these
patients to investigate potential predictors of response.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive oral lapatinib ditosylate once daily on days 1-28 and ixabepilone IV on
days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
Archival tumor tissue samples are collected for EGFR/HER2 pathway analyses via
immunohistochemistry, mRNA analysis via RT-PCR, EGFR mutation analyses, Kras and braf
mutation analysis via sequencing, and RAS mutations via PCR and sequencing. Blood samples
are also collected periodically for tumor DNA and proteomics, acetylated alpha-tubulin
analysis, EGFR-HER2 pathway genotypes, and pharmacogenomics.
After completion of study therapy, patients are followed for 30 days.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Toxicity
Assessed by NCI CTCAE v 3.0
Toxicity will be assessed at the beginning of every cycle and on day 8 and 15 of every cycle for at least eight weeks (2 cycles). Maximum of 6 cycles.
Yes
Helen K. Chew, MD
Principal Investigator
University of California, Davis
United States: Food and Drug Administration
CDR0000626165
NCT00804310
August 2009
September 2011
Name | Location |
---|---|
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
University of California Davis Cancer Center | Sacramento, California 95817 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |