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

NCT ID: NCT01332266

Last Updated: 2022-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-19
• Study Completion Date: 2017-09-04

Brief Summary

The purpose of this study is to determine whether participants with platinum-resistant squamous cell carcinoma of the head and neck (SCCHN) who receive either E7050 administered with cetuximab or cetuximab alone experience greater benefit.

Detailed Description

This open-label, multicenter, randomized study will consist of a Phase 1b: a safety run-in period with 3 ascending doses of E7050 in combination with cetuximab; and a Phase 2 portion: a randomized 2-arm period. Approximately 95 participants with platinum-resistant squamous cell carcinoma of the head and neck will be enrolled in the study (10-15 participants in the Phase 1b portion and 80 participants in the Phase 2 portion). Participants will only participate in either the Phase 1b or the Phase 2 portion of the study.

In the Phase 2 portion, participants will receive study treatment (E7050 plus cetuximab or cetuximab alone) for approximately six 28-day cycles (24 weeks). Beyond 24 weeks, participants 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.

Conditions

Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Comparator; Phase 1b: Cohort 1,2,and 3

Phase 1b:

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 2: Arm 1; MTD E7050 + 250 mg cetuximab Arm 2; 250 mg cetuximab

Interventions: Drug cetuximab

Group Type: ACTIVE_COMPARATOR

E7050

Intervention Type: DRUG

E7050 given orally at 200, 300, or 400 mg once daily.

Cetuximab

Intervention Type: DRUG

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.

Phase 2

Phase 2:

Arm 1; MTD E7050 + 250 mg/m2 cetuximab Arm 2; 250 mg/m2 cetuximab

Group Type: ACTIVE_COMPARATOR

E7050

Intervention Type: DRUG

E7050 given orally at 200, 300, or 400 mg once daily.

Cetuximab

Intervention Type: DRUG

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.

Interventions

E7050

E7050 given orally at 200, 300, or 400 mg once daily.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Golvatinib

Eligibility 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
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
• Blood pressure must be well-controlled. Participants must have no history of hypertensive crisis or hypertensive encephalopathy; Adequate end organ function

Exclusion Criteria

• Nasopharyngeal tumors
• Previously received E7050, anti-angiogenic therapy, or anti-epidermal growth factor receptor (EGFR) therapy (prior anti-angiogenic/EGFR therapy is permitted in Phase 1b only. Prior cetuximab is permitted if administered in combination with radiation
• Presence of brain metastases, unless the participant 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaBio Development Inc.

INDUSTRY

Sponsor Role: collaborator

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tucson, Arizona, United States

Fort Myers, Florida, United States

Boston, Massachusetts, United States

St Louis, Missouri, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Nashville, Tennessee, United States

Goyang-si, Gyeonggi-do, South Korea

Hwasun, Jeollanam-do, South Korea

Busan, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Dnipropetrovsk, , Ukraine

Donetsk, , Ukraine

Donetsk, , Ukraine

Kharkiv, , Ukraine

Kyiv, , Ukraine

Sumy, , Ukraine

London, Greater London, United Kingdom

Manchester, Greater Manchester, United Kingdom

Glasgow, Strathclyde, United Kingdom

Countries

United States; South Korea; Ukraine; United Kingdom

Other Identifiers

2011-000773-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E7050-702

Identifier Type: -

Identifier Source: org_study_id