Overview

This trial is active, not recruiting.

Condition platinum-resistant squamous cell carcinoma of the head and neck
Treatments e7050, cetuximab
Phase phase 1/phase 2
Target EGFR
Sponsor Eisai Inc.
Collaborator PharmaBio Development Inc.
Start date May 2011
End date May 2014
Trial size 95 participants
Trial identifier NCT01332266, 2011-000773-31, E7050-702

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Phase Ib: Cohort 1; 200 mg E7050 + 250 mg/m2 cetuximab Cohort 2; 300 mg E7050 + 250 mg/m2 cetuximab Cohort 3; 400mg E7050 + 250mg/m2 cetuximab Phase II: Arm 1; MTD E7050 + 250 mg cetuximab Arm 2; 250 mg cetuximab Interventions: Drug cetuximab
e7050
E7050 given orally at 200, 300, or 400 mg once daily.
(Active Comparator)
Phase II: Arm 1; MTD E7050 + 250 mg/m2 cetuximab Arm 2; 250 mg/m2 cetuximab
e7050
E7050 given orally at 200, 300, or 400 mg once daily.
cetuximab
Cetuximab is given at an initial dose of 400 mg/m2 given as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a dose of 250 mg/m2 given as a 1-hour IV infusion on Day 8, Day 15, and Day 22 of Cycle 1, and Day 1, Day 8, Day 15, and Day 22 of each subsequent cycle.

Primary Outcomes

Measure
Safety Parameters- Adverse Events
time frame: until study termination; 3 years
Safety Parameter- concomitant medications
time frame: until study termination; 3 years
Safety Parameter- Lab tests
time frame: Day 1 and every 28 days until study termination; 3 years
Safety Parameter- ECGs
time frame: Screening and 28 days after end of therapy; 3 years

Secondary Outcomes

Measure
Efficacy Parameter
time frame: Time Frame: Time to progression (TTP)-until the date of first documented progression of such patient's disease or death for 3 years
Efficacy Parameter
time frame: Overall survival (OS)-until the date of first documented progression of such patient's disease or death for 3 years
Efficacy Parameter
time frame: Overall response rate (ORR)-until the date of first documented progression of such patient's disease or death for 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
Description This open-label, multicenter, randomized study will consist of a Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with Cetuximab; and a Phase II portion: a randomized 2-arm period. Approximately 95 patients with Platinum-Resistant Squamous Cell Carcinoma of the head and neck will be enrolled in the study (10-15 patients in the Phase Ib portion and 80 patients in the Phase II portion). Patients will only participate in either the Phase Ib or the Phase II portion of the study. In the phase II portion, Patients will receive study treatment (E7050 plus Cetuximab or Cetuximab alone) for approximately six 28-day cycles (24 weeks). Beyond 24 weeks, patients who are experiencing clinical benefit may continue E7050 plus cetuximab, cetuximab alone or E7050 alone (Arm 1), or may continue cetuximab alone (Arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Eisai Inc..