Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
- Conditions
- Head and Neck Neoplasms
- Interventions
- Registration Number
- NCT02633800
- Lead Sponsor
- Daiichi Sankyo
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 87
- Has histologically confirmed recurrent disease or metastatic SCCHN tumor and/or from its lymph nodal metastases originating from the oral cavity, oropharynx, hypopharynx, and larynx
- 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)
- Has left ventricular ejection fraction (LVEF) <50%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin) Patritumab Cetuximab All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin) Patritumab Carboplatin All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin) Placebo Cetuximab All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin) Patritumab Cisplatin All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin) Placebo Cisplatin All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin) Placebo Carboplatin All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin) Patritumab Patritumab All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population from Day 0 to end of active study (study termination) - within 12 months PFS is defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever comes first.
Median PFS is from Kaplan-Meier analysis. Confidence interval (CI) for median was computed using Brookmeyer-Crowley method.
- Secondary Outcome Measures
Name Time Method Median Overall Survival at approximately 25 months Overall survival (OS) is defined as the time from the date of randomization to death due to any cause
Percentage of Participants With Best Overall Response at approximately 22 months Best overall response rate (ORR) is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR)
Trial Locations
- Locations (32)
Hopital Croix-Rousse
🇫🇷Lyon, France
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Institut Jules Bordet
🇧🇪Brussels, Belgium
Klinikum der Universitat Munchen
🇩🇪München, Germany
CHU Hopital de la Timone
🇫🇷Marseille, France
The Shrewsbury and Telford Hospital NHS Trust
🇬🇧Shrewsbury, United Kingdom
UZ Leuven
🇧🇪Leuven, Belgium
Medisprof SRL
🇷🇴Cluj-Napoca, Romania
Weston Park Hospital
🇬🇧Sheffield, United Kingdom
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
The Royal Marsden NHS Foundation Trust
🇬🇧Sutton, United Kingdom
Charite Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Centrul de Oncologie Sfantul Nectarie
🇷🇴Craiova, Romania
Institutul Regional de Oncologie Iasi
🇷🇴Iasi, Romania
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
🇬🇧London, United Kingdom
Institut Curie
🇫🇷Paris, Cedex, France
Institut de Cancerologie de l'Ouest
🇫🇷Saint-Herblain Cedex, France
Centre Leon Berard
🇫🇷Lyon, France
Hopital Saint Joseph
🇫🇷Marseille, France
Centre de Cancerologie du Grand Montpellier
🇫🇷Montpellier, France
Gustave Roussy
🇫🇷Villejuif, France
University College London Hospitals NHS Foundation Trust - University College Hospital
🇬🇧London, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Univeristair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Centre Hospitalier de Bordeaux - Hôpital Saint André
🇫🇷Bordeaux, France
Orszagos Onkologiai Intezet
🇭🇺Budapest, Hungary
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum
🇭🇺Debrecen, Hungary
Josa Andras Oktatokorhaz
🇭🇺Nyíregyháza, Hungary
Bacs-Kiskun Megyei Korhaz
🇭🇺Kecskemet, Hungary
Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
🇭🇺Miskolc, Hungary
Przychodnia Lekarska "KOMED"
🇵🇱Konin, Poland
Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi
🇵🇱Lodz, Poland