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A Study of MEHD7945A in Combination With Cisplatin and 5-FU or Paclitaxel and Carboplatin on Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Information source: Genentech, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer

Intervention: 5-FU (Drug); MEHD7945A (Drug); carboplatin (Drug); cisplatin (Drug); paclitaxel (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Genentech, Inc.

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Genentech, Inc.

Summary

This open-label, multicenter study will evaluate the safety, pharmacokinetics and antitumor activity of MEHD7945A in patients with recurrent/metastatic squamous cell carcinoma of the head and neck. Patients will receive MEHD7945A intravenously every 3 weeks in combination with a maximum of 6 cycles of either cisplatin plus 5-FU or carboplatin plus paclitaxel. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Clinical Details

Official title: A Phase 1b Open-Label Study of the Safety and Pharmacokinetics of MEHD7945A in Combination With Either Cisplatin and 5-FU or Paclitaxel and Carboplatin in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Safety: Incidence of adverse events

Incidence and nature of dose-limiting toxicities

Secondary outcome:

Pharmacokinetics: Area under the concentration-time curve (AUC)

Pharmacokinetics: Serum concentrations (Cmax/Cmin)

Cisplatin pharmacokinetics: Area under the concentration-time curve (AUC)

5-FU pharmacokinetics: Area under the concentration-time curve (AUC)

Carboplatin pharmacokinetics: Area under the concentration-time curve (AUC)

Paclitaxel pharmacokinetics: Area under the concentration-time curve (AUC)

Objective response rate

Disease control rate

Duration of objective response

Progression-free survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head

and neck (SCCHN) of mucosal origin (e. g., oral cavity, oropharynx, hypopharynx, larynx) that is not amenable to further curative local therapy (e. g., surgery, radiation including re-irradiation) (1L R/M)

- Patients with unknown primary SCCHN presumed to be of head and neck mucosal origin

are eligible if they meet all other entry criteria.

- For patients who present with de novo metastatic disease, no prior systemic

chemotherapy is allowed.

- For patients with recurrent SCCHN, prior systemic therapy is allowed if it was given

as part of their definitive therapy. If patients have received prior combined chemo-radiation therapy, they must be off therapy for at least 3 months.

- Consent to provide archival tumor tissue for biomarker testing

- Life expectancy >/= 12 weeks

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Disease that is measurable per modified RECIST v1. 1

- Adequate bone marrow and organ function

Exclusion Criteria:

- Nasopharyngeal cancer

- Prior treatment with an investigational or approved agent for the purpose of

inhibiting HER family members

- This includes, but is not limited to, cetuximab, panitumumab, erlotinib,

gefitinib, and lapatinib.

- Prior treatment with an EGFR inhibitor is allowed if it was administered as part

of definitive therapy for locally advanced disease and completed/terminated >/= 3 months before study enrollment.

- Major surgical procedure within 4 weeks prior to Day 1

- Leptomeningeal disease as the only manifestation of the current malignancy

- Active infection requiring antibiotics

- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory

drugs (NSAIDs)

- Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy

- Current severe, uncontrolled systemic disease

- History of cardiac heart failure of New York Heart Association Class II or greater or

serious cardiac arrhythmia requiring treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia)

- History of myocardial infarction within 6 months prior to Cycle 1, Day 1, or history

of unstable angina

- Clinically significant history of liver disease, including viral or other hepatitis,

current alcohol abuse, or cirrhosis

- History of bleeding diathesis or coagulopathy other than that due to anticoagulation

therapy

- Clinically significant GI bleeding within 6 months prior to Cycle 1, Day 1

- History of ILD

- History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic

antibodies that required discontinuation of therapy

- Known human immunodeficiency virus (HIV) infection

- Untreated/active CNS metastases (progressing or requiring anticonvulsants or

corticosteroids for symptomatic control)

- Pregnancy (positive pregnancy test) or lactation

- Malignancies other than SCCHN within 5 years prior to randomization, with the

exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix or skin (e. g., melanoma in situ)

Locations and Contacts

Bruxelles 1200, Belgium

Edegem 2650, Belgium

Leuven 3000, Belgium

Aurora, Colorado 80045, United States

Chicago, Illinois 60637, United States

Boston, Massachusetts 02114, United States

Additional Information

Starting date: September 2013
Last updated: August 17, 2015

Page last updated: August 20, 2015

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