Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy
NCT ID: NCT02780687
Last Updated: 2020-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2016-06-09
2019-09-02
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Afatinib
Afatinib
Interventions
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Afatinib
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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INS Bergonié
Bordeaux, , France
CTR Leon Berard
Lyon, , France
INS Cancérologie du Gard
Nîmes, , France
HOP Saint-Louis
Paris, , France
HOP Cochin
Paris, , France
HOP Européen G. Pompidou
Paris, , France
HOP Foch
Suresnes, , France
INS Universitaire du Cancer
Toulouse, , France
INS Gustave Roussy
Villejuif, , France
Ospedale San Donato di Arezzo
Arezzo, , Italy
A.O. San Camillo Forlanini
Roma, , Italy
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario de Elche
Elche, , Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, , Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
CIO Clara Campal
Madrid, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
CS Parc Taulí
Sabadell, , Spain
Hospital Virgen Macarena
Seville, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Countries
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References
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Font A, Mellado B, Climent MA, Virizuela JA, Oudard S, Puente J, Castellano D, Gonzalez-Del-Alba A, Pinto A, Morales-Barrera R, Rodriguez-Vida A, Fernandez PL, Teixido C, Jares P, Aldecoa I, Gibson N, Solca F, Mondal S, Lorence RM, Serra J, Real FX. Phase II trial of afatinib in patients with advanced urothelial carcinoma with genetic alterations in ERBB1-3 (LUX-Bladder 1). Br J Cancer. 2024 Feb;130(3):434-441. doi: 10.1038/s41416-023-02513-6. Epub 2023 Dec 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2015-005427-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.261
Identifier Type: -
Identifier Source: org_study_id