Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients

Part of paid clinical trials in Durham, North Carolina.

Sponsor
GlaxoSmithKline
Study ID
NCT00158782
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

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

Interventions

  • GW786034 — DRUG
    GW786034 (Pazopanib) is an orally active, potent, reversible, small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor 1 (VEGFR-1), VEGFR-2, VEGFR-3, platelet-derived growth factor receptor-alpha (PDGFR-alpha), PDGFR-beta, and c-Kit.
  • lapatinib — DRUG
    Lapatinib is an oral, reversible, tyrosine kinase inhibitor of both epidermal growth factor receptor-1 (ErbB1) and ErbB2.

Study Details

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.

Key Dates

Start date
Sep 28, 2004
Status verified
Nov 2017
Primary completion
Aug 21, 2007
Completion
Aug 21, 2007

Study Design

Enrollment
75 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Subjects will receive GW786034 500 milligrams and lapatinib 750 milligrams.
  • Experimental: Cohort 2
    Subjects will receive GW786034 250 milligrams and lapatinib 750 milligrams.
  • Experimental: Cohort 3
    Subjects will receive GW786034 250 milligrams and lapatinib 1000 milligrams.
  • Experimental: Cohort 4
    Subjects will receive GW786034 500 milligrams and lapatinib 1000 milligrams.
  • Experimental: Cohort 5
    Subjects will receive GW786034 250 milligrams and lapatinib 1250 milligrams.
  • Experimental: Cohort 6
    Subjects will receive GW786034 400 milligrams and lapatinib 1250 milligrams.
  • Experimental: Cohort 7
    Subjects will receive GW786034 200 milligrams and lapatinib 1500 milligrams.
  • Experimental: Cohort 8
    Subjects will receive GW786034 400 milligrams and lapatinib 1500 milligrams.
  • Experimental: Cohort 9
    Subjects will receive GW786034 400 milligrams and lapatinib 1000 milligrams.
  • Experimental: Cohort 10
    Subjects will receive GW786034 800 milligrams and lapatinib 1500 milligrams.

Primary Outcome Measure

Changes in pre and post treatment lab values and monitoring/reporting AES.AE's throughout study [ Time Frame: throughout study ]

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteDurhamNorth Carolina27705-

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By research site
GSK Investigational Site· Durham, NC

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