Back to resultsPatritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
Primary Purpose
Head and Neck Neoplasms
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Patritumab
Cetuximab
Cisplatin
Carboplatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Squamous cell cancer of the head and neck, Squamous cell carcinoma, Head and neck cancer, Neoplasms by site
Eligibility 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 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:
- 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
Sites / Locations
- Institut Jules Bordet
- Univeristair Ziekenhuis Antwerpen
- UZ Leuven
- Institut Curie
- Institut de Cancerologie de l'Ouest
- Centre Hospitalier de Bordeaux - Hôpital Saint André
- Hopital Croix-Rousse
- Centre Leon Berard
- CHU Hopital de la Timone
- Hopital Saint Joseph
- Centre de Cancerologie du Grand Montpellier
- Institut de Cancerologie de l'Ouest
- Gustave Roussy
- Charite Universitatsmedizin Berlin
- Medizinische Hochschule Hannover
- Klinikum der Universitat Munchen
- Orszagos Onkologiai Intezet
- Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum
- Bacs-Kiskun Megyei Korhaz
- Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
- Josa Andras Oktatokorhaz
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
- Przychodnia Lekarska "KOMED"
- Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi
- Medisprof SRL
- Centrul de Oncologie Sfantul Nectarie
- Institutul Regional de Oncologie Iasi
- University College London Hospitals NHS Foundation Trust - University College Hospital
- Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
- The Royal Marsden NHS Foundation Trust
- Weston Park Hospital
- The Shrewsbury and Telford Hospital NHS Trust
- Southampton General Hospital
- The Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Patritumab
Placebo
Arm Description
All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population
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
Median Overall Survival
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
Best overall response rate (ORR) is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR)
Full Information
NCT ID
NCT02633800
First Posted
December 15, 2015
Last Updated
December 12, 2018
Sponsor
Daiichi Sankyo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02633800
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 Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Trial was terminated by sponsor due to lack of efficacy.
Study Start Date
December 22, 2015 (Actual)
Primary Completion Date
January 11, 2018 (Actual)
Study Completion Date
February 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Squamous cell cancer of the head and neck, Squamous cell carcinoma, Head and neck cancer, Neoplasms by site
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patritumab
Arm Type
Experimental
Arm Description
All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
Intervention Type
Drug
Intervention Name(s)
Patritumab
Other Intervention Name(s)
U3-1287
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab 400 mg/mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinum-based therapy
Intervention Description
Cisplatin at 100 mg/m^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Platinum-based therapy
Intervention Description
Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match patritumab
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population
Description
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.
Time Frame
from Day 0 to end of active study (study termination) - within 12 months
Secondary Outcome Measure Information:
Title
Median Overall Survival
Description
Overall survival (OS) is defined as the time from the date of randomization to death due to any cause
Time Frame
at approximately 25 months
Title
Percentage of Participants With Best Overall Response
Description
Best overall response rate (ORR) is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR)
Time Frame
at approximately 22 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Harrington, Prof, MD
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Univeristair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Institut Curie
City
Paris
State/Province
Cedex
ZIP/Postal Code
75248
Country
France
Facility Name
Institut de Cancerologie de l'Ouest
City
Angers cedex 02
ZIP/Postal Code
49055
Country
France
Facility Name
Centre Hospitalier de Bordeaux - Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hopital Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CHU Hopital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Centre de Cancerologie du Grand Montpellier
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Institut de Cancerologie de l'Ouest
City
Saint-Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
12200/12203
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinikum der Universitat Munchen
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Korhaz
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Josa Andras Oktatokorhaz
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Przychodnia Lekarska "KOMED"
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Medisprof SRL
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
Centrul de Oncologie Sfantul Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
University College London Hospitals NHS Foundation Trust - University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
The Shrewsbury and Telford Hospital NHS Trust
City
Shrewsbury
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
IPD Sharing Time Frame
Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States and the European Union from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
Citations:
PubMed Identifier
31648099
Citation
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.
Results Reference
derived
Learn more about this trial
Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
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