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

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. Read our disclaimer for details. Identifier: NCT02780687
Recruitment Status : Completed
First Posted : May 23, 2016
Last Update Posted : September 6, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

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 or disease Intervention/treatment Phase
Urologic Neoplasms Drug: Afatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 participants
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.
Actual Study Start Date : June 9, 2016
Actual Primary Completion Date : September 24, 2018
Actual Study Completion Date : September 2, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Afatinib Drug: Afatinib

Primary Outcome Measures :
  1. 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 :
  1. 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) ]
  2. 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 ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT02780687

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INS Bergonié
Bordeaux, France, 33076
CTR Leon Berard
Lyon, France, 69373
INS Cancérologie du Gard
Nîmes, France, 30029
HOP Saint-Louis
Paris, France, 75010
HOP Cochin
Paris, France, 75014
HOP Européen G. Pompidou
Paris, France, 75015
HOP Foch
Suresnes, France, 92150
INS Claudius Regaud
Toulouse, France, 31059
INS Gustave Roussy
Villejuif, France, 94805
Ospedale San Donato di Arezzo
Arezzo, Italy, 52100
A.O. San Camillo Forlanini
Roma, Italy, 00152
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Hospital del Mar
Barcelona, Spain, 08003
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital Vall d'Hebron
Barcelona, Spain, 08038
Hospital Universitario de Elche
Elche, Spain, 03202
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain, 17007
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 08908
Hospital Universitario Lucus Augusti
Lugo, Spain, 27003
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital La Paz
Madrid, Spain, 28046
CIO Clara Campal
Madrid, Spain, 28050
Hospital Son Espases
Palma de Mallorca, Spain, 07010
CS Parc Taulí
Sabadell, Spain, 08208
Hospital Virgen Macarena
Sevilla, Spain, 41009
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT02780687     History of Changes
Other Study ID Numbers: 1200.261
2015-005427-10 ( EudraCT Number )
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action