Randomisation system
log-in to secure server here

Overview

LaMB is a phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after first-line chemotherapy in patients with HER1 and/or HER2 overexpressing locally advanced or metastatic bladder cancer. The primary objective is to compare progression free survival between patients receiving lapatinib and placebo.

Inclusion criteria

• Histologically confirmed metastatic or locally advanced stage IV bladder cancer
• Able to commence study drug 3-8 weeks after completion of 1st line chemo for metastatic bladder cancer
• HER1 and/or HER 2 positive, confirmed by central lab
• Objective response or stable disease following 4-8 cycles of first-line chemotherapy
• ECOG performance status 0-3
• Left ventricular ejection fraction (LVEF) within normal range as measured by ECHO or MUGA

Exclusion criteria

• Progression with first-line chemotherapy for metastatic disease
• Previous anti-HER1 or HER2 therapy
• More than one line of chemotherapy for metastatic or locally advanced disease
• Patients receiving radical/curative therapy at the end of first line treatment
• Significant cardiac disease
• Patients receiving less than 4 or more than 8 cycles of chemotherapy before randomisation
• Major surgery or curative radiotherapy after chemotherapy (palliative radiotherapy is allowed)

Chief Investigator

Thomas Powles MD MRCP
Consultant in Medical Oncology
Centre for Experimental Cancer Medicine
Institute of Cancer, Barts and The London School of Medicine and Dentistry

Eudract number: 2007-001826-28

Further information and assistance

Please contact the trial coordination team:

Randomisation service provided by: Sealed Envelope™.com