Spots Global Cancer Trial Database for Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
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Trial Identification
Brief Title: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
Official Title: Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT02633800
Conditions
Study Description
Brief Summary: This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.
Detailed Description: Main objective of the trial: The main objective of the trial is to evaluate progression-free survival (PFS) in the heregulin (HRG) high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institut Jules Bordet, Brussels, , Belgium
Univeristair Ziekenhuis Antwerpen, Edegem, , Belgium
UZ Leuven, Leuven, , Belgium
Institut Curie, Paris, Cedex, France
Institut de Cancerologie de l'Ouest, Angers cedex 02, , France
Centre Hospitalier de Bordeaux - Hôpital Saint André, Bordeaux, , France
Hopital Croix-Rousse, Lyon, , France
Centre Leon Berard, Lyon, , France
CHU Hopital de la Timone, Marseille, , France
Hopital Saint Joseph, Marseille, , France
Centre de Cancerologie du Grand Montpellier, Montpellier, , France
Institut de Cancerologie de l'Ouest, Saint-Herblain Cedex, , France
Gustave Roussy, Villejuif, , France
Charite Universitatsmedizin Berlin, Berlin, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Klinikum der Universitat Munchen, München, , Germany
Orszagos Onkologiai Intezet, Budapest, , Hungary
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum, Debrecen, , Hungary
Bacs-Kiskun Megyei Korhaz, Kecskemet, , Hungary
Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Miskolc, , Hungary
Josa Andras Oktatokorhaz, Nyíregyháza, , Hungary
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz, , Poland
Przychodnia Lekarska "KOMED", Konin, , Poland
Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi, Lodz, , Poland
Medisprof SRL, Cluj-Napoca, , Romania
Centrul de Oncologie Sfantul Nectarie, Craiova, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
University College London Hospitals NHS Foundation Trust - University College Hospital, London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
The Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
Name: Kevin Harrington, Prof, MD
Affiliation: Royal Marsden NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR
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