Skip to main content
MedPathMedPath Home
Clinical Trials/ISRCTN35418671
ISRCTN35418671
Completed
Phase 2

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

Queen Mary, University of London (UK)0 sites232 target enrollmentMarch 31, 2010
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsTopic: National Cancer Research NetworkSubtopic: Bladder CancerDisease: Bladder (advanced)CancerBladder Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Topic: National Cancer Research Network
Sponsor
Queen Mary, University of London (UK)
Enrollment
232
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2015 Results article in https://dx.doi.org/10.1002/cam4.432 results 2017 Results article in http://dx.doi.org/10.1200/JCO.2015.66.3468 results

Registry
who.int
Start Date
March 31, 2010
End Date
June 1, 2011
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Queen Mary, University of London (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Histologically confirmed metastatic or locally advanced stage IV transitional cell carcinoma of the urothelium
  • •2\. Able to commence study drug 3 \- 8 weeks after completion of 1st line chemotherapy for metastatic bladder cancer
  • •3\. HER1 and/or HER 2 positive, confirmed by central lab
  • •4\. Objective response or stable disease following 4 \- 8 cycles of first\-line chemotherapy
  • •5\. Eastern Cooperative Oncology Group (ECOG) performance status 0 \- 3
  • •6\. Left ventricular ejection fraction (LVEF) within normal range as measured by ECHO or MUGA
  • •7\. Written informed consent
  • •8\. Aged over 18 years, either sex

Exclusion Criteria

  • •1\. Progression with first\-line chemotherapy for metastatic disease
  • •2\. Previous anti\-HER1 or HER2 therapy
  • •3\. More than one line of chemotherapy for metastatic or locally advanced disease
  • •4\. Significant cardiac disease
  • •5\. Patients receiving less than 4 or more than 8 cycles of chemotherapy before randomisation
  • •6\. Major surgery or curative radiotherapy after chemotherapy (palliative radiotherapy is allowed)

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Phase 3
Effect of the SCAR CLEARING GEL to treat Scars.
CTRI/2023/09/058063Pontika Aerotech Ltd.30
Completed
Phase 2
Which treatment could lessen the severity of a coronavirus infection when compared with usual care in an NHS setting?COVID-19 (SARS-CoV-2 infection) in hospitalised patientsRespiratoryCOVID-19 (SARS-CoV-2 infection)
ISRCTN40580903niversity of Birmingham146
Completed
Phase 3
A phase III multicentre double blind randomised trial of celecoxib versus placebo in primary breast cancer patientsBreast cancerCancer
ISRCTN48254013Imperial College of Science and Technology (UK)2,639
Completed
Not Applicable
Three arm randomized parallel phase II/III study evaluating the efficacy and safety of the combinations Epirubicin and Taxotere (ET), Taxotere and Navelbine (TN) and Navelbine and Epirubicin (EN) as first line therapy in pat. with metastatic breast cancer.Metastic breast cancer.
NL-OMON29407VU medical center.111
Completed
Phase 3
A two-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage Small Cell Lung Cancer (SCLC) and good performance status
ISRCTN91927162Christie Hospital NHS Foundation Trust547