Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients
Status:
Completed
Trial end date:
2007-08-21
Target enrollment:
Participant gender:
Summary
This Phase I, dose finding study evaluates the safety and tolerability of lapatinib, a dual
tyrosine kinase inhibitor, and GW786034, an anti-angiogenesis agent, when given together. The
study first will find the best doses using safety and blood concentration data of both
agents. This is done enrolling stepwise, cohorts of 3 patients each and the last patient
enrolled must reach at least Day 22 of continuous daily dosing before the next cohort at an
increased dose can begin. If a patient in a cohort has a dose limiting toxicity before Day
22, then 3 more patients are studied at that same dose. If 2 of 6 patients have dose limiting
toxicities within the first 22 days, the next cohort receives the next lowest dose. Otherwise
each cohort has an increasing dose of one of the two agents. The second stage of the study
will administer the best doses of the agents to about 16 patients to further study safety and
collect more blood concentration data (more blood samples in the second phase compared to the
first phase). The second stage has the advantage of using the best dose (decreases chance of
receiving a sub-therapeutic dose) while it collects more blood samples and requires slightly
more long clinic visits.