Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects With Documented Tumor Progression After Chemotherapy, or Where no Approved Therapy Exists

Part of paid clinical trials in Denver, Colorado.

Sponsor
GlaxoSmithKline
Study ID
NCT00447226
Phase
PHASE2
Status
Terminated

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • Oral lapatinib tablets or placebo tablets — DRUG
    Subjects administered open label lapatinib, 1500 mg to be taken orally once a day, for 12 weeks. After 12 weeks, subjects with a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) will continue to receive open label lapatinib (1500 mg/day orally) until disease progression. Subjects who maintain stable disease will be randomized in a 1:1 ratio to enter stage 2 of the study and receive double blind therapy of either lapatinib 1500 mg/day orally or placebo. Subjects who progress on placebo will have the option to receive lapatinib 1500 mg/day orally until further progression. Those who progress on lapatinib will be withdrawn from the study.

Study Details

This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.

Key Dates

Start date
May 31, 2007
Status verified
Jun 2012
Primary completion
May 31, 2009
Completion
Sep 30, 2009

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib Oral Tablets
  • Placebo Comparator: Placebo Control

Primary Outcome Measure

Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose [ Time Frame: Week 12 ]

Locations (20)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteDenverColorado80218-
GSK Investigational SiteIndianapolisIndiana46219-
GSK Investigational SiteOverland ParkKansas66210-
GSK Investigational SiteMinneapolisMinnesota55404-
GSK Investigational SiteSt LouisMissouri63141-
GSK Investigational SiteLas VegasNevada89109-
GSK Investigational SiteAlbanyNew York12206-
GSK Investigational SiteRaleighNorth Carolina27607-
GSK Investigational SiteGreenvilleSouth Carolina29605-
GSK Investigational SiteAustinTexas78731-
GSK Investigational SiteBedfordTexas76022-
GSK Investigational SiteDallasTexas75246-
GSK Investigational SiteEl PasoTexas79915-
GSK Investigational SiteFort WorthTexas76104-
GSK Investigational SiteTylerTexas75702-
GSK Investigational SiteWebsterTexas77598-4420-
GSK Investigational SiteLeesburgVirginia20176-
GSK Investigational SiteNewport NewsVirginia23606-
GSK Investigational SiteSpokaneWashington99202-
GSK Investigational SiteVancouverWashington98684-

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GSK Investigational Site· Denver, COGSK Investigational Site· Indianapolis, INGSK Investigational Site· Overland Park, KSGSK Investigational Site· Minneapolis, MNGSK Investigational Site· St Louis, MOGSK Investigational Site· Las Vegas, NV

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