Pazopanib Plus Lapatinib Compared to Lapatinib Alone and Pazopanib Alone In Subjects With Metastatic Cervical Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
GlaxoSmithKline
Study ID
NCT00430781
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Cervical Cancer
  • Neoplasms, Uterine Cervix

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pazopanib (GW786034) — DRUG
  • lapatinib (GW572016) — DRUG

Study Details

This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer

Key Dates

Start date
Nov 30, 2006
Status verified
Apr 2015
Primary completion
Jul 31, 2008
Completion
Jul 31, 2011

Study Design

Enrollment
228 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination arm
    Pazopanib plus lapatinib
  • Active Comparator: Lapatinib monotherapy
    Lapatinib
  • Active Comparator: Pazopanib monotherapy
    Pazopanib

Primary Outcome Measure

Progression-free Survival (PFS) in Interim Analysis [ Time Frame: From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks) ]

Locations (12)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLos AngelesCalifornia90033-
GSK Investigational SiteOrangeCalifornia92868-
GSK Investigational SiteStanfordCalifornia94305-5317-
GSK Investigational SiteAugustaGeorgia30912-
GSK Investigational SiteBostonMassachusetts02115-
GSK Investigational SiteAlbuquerqueNew Mexico87131-5276-
GSK Investigational SiteNew YorkNew York10016-
GSK Investigational SiteClevelandOhio44106-
GSK Investigational SiteColumbusOhio43214-
GSK Investigational SiteOklahoma CityOklahoma73104-
GSK Investigational SiteChattanoogaTennessee37403-
GSK Investigational SiteDallasTexas75390-

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