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

Daiichi Sankyo

Status and phase: Terminated; Phase 2

Conditions: Head and Neck Neoplasms

Treatments: Drug: Patritumab; Drug: Carboplatin; Drug: Cetuximab; Drug: Cisplatin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02633800

2015-002222-40 (EudraCT Number)

U31287-A-U203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups, including a placebo group

Patritumab

Experimental group

Description:

All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)

Treatment:

Drug: Carboplatin

Drug: Cetuximab

Drug: Cisplatin

Drug: Patritumab

Placebo

Placebo Comparator group

Description:

All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)

Treatment:

Drug: Carboplatin

Drug: Cetuximab

Drug: Cisplatin

Drug: Placebo