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Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy (LUX-Bladder 1)

This study is currently recruiting participants.
Verified December 2017 by Boehringer Ingelheim
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780687
First Posted: May 23, 2016
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose

The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 mutations or ERBB2 amplifications (Cohort A), and EGFR amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis.

The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR).


Condition Intervention Phase
Urologic Neoplasms Drug: Afatinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LUX-Bladder 1: Phase II Open Label Single Arm Exploratory Trial of Oral Afatinib Monotherapy Following Platinum Failure for Patients With Advanced/Metastatic Urothelial Tract Carcinoma With Genetic Alterations in ERBB Receptors.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Progression Free Survival at 6 months in Cohort A (defined as the proportion of patients who does not show disease progression by the 24-week tumour assessment). [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Objective response rate (ORR) in Cohort A, defined as number of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1. [ Time Frame: From Baseline to disease progression (up to 2 years) ]
  • Progression free survival (PFS) in Cohort A, defined as the time from first drug administration to the date of disease progression, or date of death whichever is earlier [ Time Frame: Starting with first drug administration and until up to 2 years for each patient ]
  • Overall Survival (OS) in Cohort A, defined as the time from first drug administration to the date of death [ Time Frame: From first drug administration to date of death (up to 5 years) ]
  • Disease Control Rate (DCR) in Cohort A, defined as complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-Progressive Disease (NN) according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 [ Time Frame: From first drug administration to disease progression (up to 2 years) ]
  • Duration of objective response (DOR) in Cohort A, according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 [ Time Frame: From first drug administration to disease progression (up to 2 years) ]
  • Tumour shrinkage in Cohort A, measured as the maximum percentage decrease from baseline sum of target lesion diameters after treatment until disease progression [ Time Frame: From first drug administration to disease progression (up to 2 years) ]

Estimated Enrollment: 80
Actual Study Start Date: June 9, 2016
Estimated Study Completion Date: March 29, 2019
Estimated Primary Completion Date: February 28, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Afatinib Drug: Afatinib

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Recurrent or metastatic urothelial cancer
  • Patients must have failed prior platinum based treatment (adjuvant or 1st line)
  • Archival tissue sample available for biomarker testing at pre-screening and tissue banking.
  • Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification.
  • Further inclusion criteria apply

Exclusion criteria:

  • Prior use of EGFR, ERBB2 or ERBB3 targeted treatment
  • Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
  • Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis
  • Further exclusion criteria apply
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780687


Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
France
INS Bergonié Recruiting
Bordeaux, France, 33076
CTR Léon Bérard Recruiting
Lyon, France, 69373
HOP Carémeau Recruiting
Nimes, France, 30029
HOP Saint-Louis Recruiting
Paris Cédex 10, France, 75010
HOP Cochin Recruiting
Paris, France, 75014
HOP Européen G. Pompidou Recruiting
Paris, France, 75015
INS Universitaire du Cancer Recruiting
Toulouse, France, 31059
Italy
Ospedale San Donato di Arezzo Recruiting
Arezzo, Italy, 52100
A.O. San Camillo Forlanini Recruiting
Roma, Italy, 00152
Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Spain, 08916
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08038
Hospital Universitario de Elche Recruiting
Elche, Spain, 03202
Hospital Universitari de Girona Doctor Josep Trueta Recruiting
Girona, Spain, 17007
Hospital Duran i Reynals Recruiting
L'Hospitalet de Llobregat, Spain, 08908
Hospital Universitario Lucus Augusti Recruiting
Lugo, Spain, 27003
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital La Paz Recruiting
Madrid, Spain, 28046
CIO Clara Campal Recruiting
Madrid, Spain, 28050
Hospital Son Espases Recruiting
Palma de Mallorca, Spain, 07010
CS Parc Taulí Recruiting
Sabadell, Spain, 08208
Hospital Virgen Macarena Recruiting
Sevilla, Spain, 41009
Hospital Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Instituto Valenciano de Oncología Recruiting
Valencia, Spain, 46009
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02780687     History of Changes
Other Study ID Numbers: 1200.261
2015-005427-10 ( EudraCT Number )
First Submitted: May 20, 2016
First Posted: May 23, 2016
Last Update Posted: December 14, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms