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Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02633800
First received: December 15, 2015
Last updated: June 23, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Head and Neck Neoplasms Drug: Patritumab Drug: Cetuximab Drug: Cisplatin Drug: Carboplatin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Randomized, Placeo-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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Mean Progression Free Survival [ Time Frame: from Day 0 to end of active study, approximately 22 months ]
    Progression free survival is defined as time to first objective documentation of radiographic disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 or death due to any cause


Secondary Outcome Measures:
  • Mean Overall Survival [ Time Frame: from Day 0 to end of study follow-up, 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 [ Time Frame: from Day 0 to end of active study, approximately 22 months ]
    Best overall response rate (ORR) is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR)


Estimated Enrollment: 105
Study Start Date: December 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patritumab
All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
Drug: 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
Other Name: U3-1287
Drug: Cetuximab
Cetuximab 400 mg/mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly
Drug: Cisplatin
Cisplatin at 100 mg/m^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
Other Name: Platinum-based therapy
Drug: Carboplatin
Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
Other Name: Platinum-based therapy
Placebo Comparator: Placebo
All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
Drug: Cetuximab
Cetuximab 400 mg/mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly
Drug: Cisplatin
Cisplatin at 100 mg/m^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
Other Name: Platinum-based therapy
Drug: Carboplatin
Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
Other Name: Platinum-based therapy
Drug: Placebo
Placebo to match patritumab

  Eligibility

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

Inclusion Criteria:

  • 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 proocol
  • 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:

  • Has left ventricular ejection fraction (LVEF) <50%
  • Had prior EGFR targeted regimen
  • Had prior 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02633800

Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Univeristair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
UZ Leuven
Leuven, Belgium, 3000
France
Institut Curie
Paris, Cedex, France, 75248
Institut de Cancerologie de l'Ouest
Angers cedex 02, France, 49055
Centre Hospitalier de Bordeaux - Hôpital Saint André
Bordeaux, France, 33075
Hopital Croix-Rousse
Lyon, France, 69004
Centre Leon Berard
Lyon, France, 69373
CHU Hopital de la Timone
Marseille, France, 13005
Hopital Saint Joseph
Marseille, France, 13008
Centre de Cancerologie du Grand Montpellier
Montpellier, France, 34070
Institut de Cancerologie de l'Ouest
Saint-Herblain Cedex, France, 44805
Gustave Roussy
Villejuif, France, 94805
Germany
Charite Universitatsmedizin Berlin
Berlin, Germany, 12200/12203
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Klinikum der Universitat Munchen
München, Germany, 81377
Hungary
Orszagos Onkologiai Intezet
Budapest, Hungary, 1122
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum
Debrecen, Hungary, 4032
Bacs-Kiskun Megyei Korhaz
Kecskemet, Hungary, 6000
Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, Hungary, 3526
Josa Andras Oktatokorhaz
Nyíregyháza, Hungary, 4400
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, Poland, 85-796
Przychodnia Lekarska "KOMED"
Konin, Poland, 62-500
Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi
Lodz, Poland, 93-513
Romania
Medisprof SRL
Cluj-Napoca, Romania, 400058
Centrul de Oncologie Sfantul Nectarie
Craiova, Romania, 200347
Institutul Regional de Oncologie Iasi
Iasi, Romania, 700483
United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London, United Kingdom, NW1 2PG
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, United Kingdom, SE1 7EH
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
The Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, United Kingdom, SY3 8XQ
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Daiichi Sankyo Inc.
Covance
Investigators
Principal Investigator: Kevin Harrington, Prof, MD Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT02633800     History of Changes
Other Study ID Numbers: U31287-A-U203
2015-002222-40 ( EudraCT Number )
Study First Received: December 15, 2015
Last Updated: June 23, 2017

Keywords provided by Daiichi Sankyo Inc.:
Squamous cell cancer of the head and neck
Squamous cell carcinoma
Head and neck cancer
Neoplasms by site

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Cetuximab
Carboplatin
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017