A Double Blind Randomised Study of Lapatinib and Placebo in Metastatic TCC of the Urothelium

Sponsor
Queen Mary University of London
Study ID
NCT00949455
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • lapatinib ditosylate — DRUG
    Given orally
  • Placebo — OTHER
    Given orally

Study Details

RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether lapatinib ditosylate is more effective than a placebo in killing tumor cells. PURPOSE: This randomized phase II/III trial is studying how well lapatinib ditosylate works compared to a placebo in treating patients with stage IV bladder cancer.

Key Dates

Start date
Mar 31, 2009
Status verified
Apr 2015
Primary completion
Jul 31, 2015

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Patients receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity.
  • Placebo Comparator: Arm II
    Patients receive oral placebo once daily in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression free survival [ Time Frame: Disease Progression - at least 20% increase in the sum of longest diameters of target lesions. ]

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