Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma ... | Not Recruiting
Patritumab With Cetuximab and a Pla... | Not Recruiting
Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Head and Neck Neoplasms
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02633800
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Patritumab, Drug : Cetuximab, Drug : Cisplatin, Drug : Carboplatin, Drug : Placebo

Study Arm Groups : Patritumab, Patritumab, Placebo, Patritumab, Placebo, Patritumab, Placebo, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Mean Progression Free Survival; from Day 0 to end of active study, approximately 22 months
Secondary Outcome Measures
    Mean Overall Survival; from Day 0 to end of study follow-up, approximately 25 months; Percentage of Participants with Best Overall Response; from Day 0 to end of active study, approximately 22 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
SE1 7EH
Southampton General Hospital
Southampton
England
SO16 6YD
Royal Marsden - Surrey
Sutton
England
SM2 5PT
London
NW1 2PG
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Sheffield
S10 2SJ
Royal Shrewsbury Hospital
Shrewsbury
England
SY3 8XQ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Belgium, France, Germany, Hungary, Poland, Romania, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
  • Covance
Other Study ID Numbers
U31287-A-U203
Sponsor(s)
Daiichi Sankyo, Inc.
Key Dates

Recruitment Start Date

Dec 2015

Recruitment End Date

Oct 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

15 Dec 2015

Date updated in source

23 Aug 2017