Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients
- Registration Number
- NCT00158782
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 2 lapatinib Subjects will receive GW786034 250 milligrams and lapatinib 750 milligrams. Cohort 3 GW786034 Subjects will receive GW786034 250 milligrams and lapatinib 1000 milligrams. Cohort 1 GW786034 Subjects will receive GW786034 500 milligrams and lapatinib 750 milligrams. Cohort 1 lapatinib Subjects will receive GW786034 500 milligrams and lapatinib 750 milligrams. Cohort 3 lapatinib Subjects will receive GW786034 250 milligrams and lapatinib 1000 milligrams. Cohort 4 GW786034 Subjects will receive GW786034 500 milligrams and lapatinib 1000 milligrams. Cohort 4 lapatinib Subjects will receive GW786034 500 milligrams and lapatinib 1000 milligrams. Cohort 5 lapatinib Subjects will receive GW786034 250 milligrams and lapatinib 1250 milligrams. Cohort 6 lapatinib Subjects will receive GW786034 400 milligrams and lapatinib 1250 milligrams. Cohort 7 GW786034 Subjects will receive GW786034 200 milligrams and lapatinib 1500 milligrams. Cohort 7 lapatinib Subjects will receive GW786034 200 milligrams and lapatinib 1500 milligrams. Cohort 8 GW786034 Subjects will receive GW786034 400 milligrams and lapatinib 1500 milligrams. Cohort 10 lapatinib Subjects will receive GW786034 800 milligrams and lapatinib 1500 milligrams. Cohort 10 GW786034 Subjects will receive GW786034 800 milligrams and lapatinib 1500 milligrams. Cohort 2 GW786034 Subjects will receive GW786034 250 milligrams and lapatinib 750 milligrams. Cohort 5 GW786034 Subjects will receive GW786034 250 milligrams and lapatinib 1250 milligrams. Cohort 6 GW786034 Subjects will receive GW786034 400 milligrams and lapatinib 1250 milligrams. Cohort 9 GW786034 Subjects will receive GW786034 400 milligrams and lapatinib 1000 milligrams. Cohort 8 lapatinib Subjects will receive GW786034 400 milligrams and lapatinib 1500 milligrams. Cohort 9 lapatinib Subjects will receive GW786034 400 milligrams and lapatinib 1000 milligrams.
- Primary Outcome Measures
Name Time Method Labs every wk first cycle:day 1 subsequent cycles first cycle:day 1 subsequent cycles Changes in pre and post treatment lab values and monitoring/reporting AES.AE's throughout study throughout study
- Secondary Outcome Measures
Name Time Method find max conc of drugs in blood and time it occurs find out if drugs are taken up by the body, how much/for how long find out if drugs affect the size of the tumor. Blood taken day 15, 22 or 37 and tumor assessed every 8 wks Blood taken day 15, 22 or 37 and tumor assessed every 8 wks
Trial Locations
- Locations (1)
GSK Investigational Site
🇳🇱Rotterdam, Netherlands
GSK Investigational Site🇳🇱Rotterdam, Netherlands