Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158782
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2005-09-08
Brief Title:
Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open-Label Safety Pharmacokinetic and Pharmacodynamic Study of Multiple Doses of GW786034 and Lapatinib Concomitantly Administered in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None