Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
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| ClinicalTrials.gov Identifier: NCT02633800 |
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Recruitment Status :
Terminated
(Trial was terminated by sponsor due to lack of efficacy.)
First Posted : December 17, 2015
Results First Posted : January 7, 2019
Last Update Posted : January 7, 2019
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Sponsor:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Neoplasms | Drug: Patritumab Drug: Cetuximab Drug: Cisplatin Drug: Carboplatin Drug: Placebo | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 87 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | December 22, 2015 |
| Actual Primary Completion Date : | January 11, 2018 |
| Actual Study Completion Date : | February 21, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Head and neck squamous cell carcinoma
MedlinePlus related topics:
Head and Neck Cancer
Drug Information available for:
Cetuximab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Patritumab
All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
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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 |
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Placebo Comparator: Placebo
All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
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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 |
Primary Outcome Measures :
- Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population [ Time Frame: 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 :
- Median Overall Survival [ Time Frame: 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 [ Time Frame: at approximately 22 months ]Best overall response rate (ORR) is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633800
Locations
Show 34 study locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
| Principal Investigator: | Kevin Harrington, Prof, MD | Royal Marsden NHS Foundation Trust |
Study Documents (Full-Text)
Documents provided by Daiichi Sankyo, Inc.:
Documents provided by Daiichi Sankyo, Inc.:
Study Protocol [PDF] June 14, 2016
Statistical Analysis Plan [PDF] November 29, 2016
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daiichi Sankyo, Inc. |
| ClinicalTrials.gov Identifier: | NCT02633800 |
| Other Study ID Numbers: |
U31287-A-U203 2015-002222-40 ( EudraCT Number ) |
| First Posted: | December 17, 2015 Key Record Dates |
| Results First Posted: | January 7, 2019 |
| Last Update Posted: | January 7, 2019 |
| Last Verified: | December 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code |
| 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. |
| 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. |
| URL: | https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Daiichi Sankyo, Inc.:
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Squamous cell cancer of the head and neck Squamous cell carcinoma Head and neck cancer Neoplasms by site |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Neoplasms by Site Carboplatin Cetuximab Antineoplastic Agents Antineoplastic Agents, Immunological |