E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Trial end date: 2017-09-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether patients with Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck who receive either E7050 administered with Cetuximab or Cetuximab alone experience greater benefit

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Collaborator: PharmaBio Development Inc.
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Platinum-resistant (defined as failure to respond to treatment with a platinum agent or recurrence of disease after initial response to platinum within 12 months of completing therapy), locally advanced, recurrent and/or metastatic SCCHN, which is untreatable by surgical resection or radiation therapy;

• ECOG PS of 0-2;

• Blood pressure must be well-controlled. Patients must have no history of hypertensive crisis or hypertensive encephalopathy; Adequate end organ function

Exclusion Criteria

• Nasopharyngeal tumors;

• Previously received E7050, anti-cmet, anti-angiogenic therapy, or anti-EGFR therapy (prior anti-angiogenic/EGFR therapy is permitted in Phase Ib only. Prior cetuximab is permitted if administered in combination with radiation;

• Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;

• Palliative radiotherapy is not permitted throughout the study period;

• Clinically significant hemoptysis;

• Serious non-healing wound, ulcer, or active bone fracture;

• Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for a major surgical procedure during the course of the study;

• Clinically significant gastrointestinal bleeding within 6 months prior to first dose.