Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
NCT ID: NCT02633800
Last Updated: 2019-01-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
87 participants
INTERVENTIONAL
2015-12-22
2018-02-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Patritumab
All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
Patritumab
Patritumab initial loading dose is 18 mg/kg IV over 60 minutes followed by a maintenance dose of 9 mg/kg IV over 60 minutes (± 10 minutes) every three weeks
Cetuximab
Cetuximab 400 mg/mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
Cisplatin
Cisplatin at 100 mg/m\^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
Carboplatin
Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
Placebo
All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
Cetuximab
Cetuximab 400 mg/mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
Cisplatin
Cisplatin at 100 mg/m\^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
Carboplatin
Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
Placebo
Placebo to match patritumab
Interventions
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Patritumab
Patritumab initial loading dose is 18 mg/kg IV over 60 minutes followed by a maintenance dose of 9 mg/kg IV over 60 minutes (± 10 minutes) every three weeks
Cetuximab
Cetuximab 400 mg/mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
Cisplatin
Cisplatin at 100 mg/m\^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
Carboplatin
Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
Placebo
Placebo to match patritumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has or be willing to provide tumor tissue for testing
* Has measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1
* Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Has adequate hematological function per protocol
* Has adequate renal function per protocol
* Has adequate hepatic function per protocol
* Agrees to use effective contraception while on the study and for 6-months after the end of the study
* Provides written informed consent(s)
Exclusion Criteria
* Had prior epidermal growth factor receptor (EGFR) targeted regimen
* Had prior anti-human epidermal growth factor receptor 3 (anti-HER3) therapy
* Had prior chemotherapy for recurrent/metastatic disease
* Had anti-cancer therapy between biopsy and submission of sample
* Has history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
* Has known history of brain metastases or active brain metastases
* Has uncontrolled hypertension
* Has clinically significant electrocardiograph (ECG) findings
* Had myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or arrhythmia requiring medication
* Had platinum-containing drug therapy with radiotherapy less than 6 months before study drug treatment
* Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Harrington, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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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, , 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, , France
Gustave Roussy
Villejuif, , France
Charite Universitatsmedizin Berlin
Berlin, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum der Universitat Munchen
München, , Germany
Orszagos Onkologiai Intezet
Budapest, , Hungary
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum
Debrecen, , Hungary
Bacs-Kiskun Megyei Korhaz
Kecskemét, , 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
Iași, , 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
Countries
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References
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Barber PR, Mustapha R, Flores-Borja F, Alfano G, Ng K, Weitsman G, Dolcetti L, Suwaidan AA, Wong F, Vicencio JM, Galazi M, Opzoomer JW, Arnold JN, Thavaraj S, Kordasti S, Doyle J, Greenberg J, Dillon MT, Harrington KJ, Forster M, Coolen ACC, Ng T. Predicting progression-free survival after systemic therapy in advanced head and neck cancer: Bayesian regression and model development. Elife. 2022 Dec 23;11:e73288. doi: 10.7554/eLife.73288.
Forster MD, Dillon MT, Kocsis J, Remenar E, Pajkos G, Rolland F, Greenberg J, Harrington KJ. Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study. Eur J Cancer. 2019 Dec;123:36-47. doi: 10.1016/j.ejca.2019.08.017. Epub 2019 Oct 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-002222-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U31287-A-U203
Identifier Type: -
Identifier Source: org_study_id
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