Phase 2
N=12
E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT01332266 ↗Enrolled (actual)
12
Serious AEs
39.0%
Results posted
Jan 2022
Primary outcome: Primary: Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- E7050 (Drug); Cetuximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) |
0; 0; 0 | — |
| PRIMARY Phase 1b: Plasma Concentration of Golvatinib When Given in Combination With Cetuximab |
— | — |
| PRIMARY Phase 2: Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) |
21; 21 | — |
| PRIMARY Phase 2: Number of Participants With Markedly Abnormal Vital Sign Values |
0; 0 | — |
| PRIMARY Phase 2: Number of Participants With Markedly Abnormal Physical Examinations Findings |
5; 6; 20; 17; 24; 22 | — |
| PRIMARY Phase 2: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values |
0; 0 | — |
| SECONDARY Phase 2: Progression-free Survival (PFS) |
15.71; 15.71 | — |
| SECONDARY Phase 2: Percentage of Participants With PFS at Week 12 |
68.9; 59.4 | — |
| SECONDARY Phase 2: Time to Progression (TTP) |
15.43; 16.00 | — |
| SECONDARY Phase 2: Overall Survival (OS) |
39.71; 36.71 | — |
| SECONDARY Phase 2: Percentage of Participants With Overall Response |
9.5; 4.9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01332266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.