Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Brief summary
Overall survival (OS), defined as the time from the date of randomization to the date of death for any cause
Detailed description
1. Progression-free survival (PFS), defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by the Investigator, or death from any cause, whichever occurs first, 2. Objective response rate (ORR), defined as the percentage of participants who have a complete response (CR) or a partial response (PR) per RECIST v1.1 as assessed by the Investigator, 3. Disease control rate (DCR), defined as the percentage of participants who have achieved a CR, PR, or stable disease (SD) for at least 8 weeks per RECIST v1.1 (as assessed by the Investigator), 4. Duration of response (DOR), defined for participants who have a confirmed CR or PR as the time from the date of first documented response (which is subsequently confirmed) per RECIST v1.1, as assessed by the Investigator, until date of documented PD or death due to any cause, whichever occurs first, 5. Incidence and severity of adverse events (AEs); Incidence and severity of laboratory abnormalities, 6. Concentrations of ficlatuzumab in serum samples, 7. The presence of anti-drug antibodies (ADA) to ficlatuzumab based on seroconversion status, and the evaluation of the potential impact of ADA on PK, efficacy, and safety • The presence of neutralizing antibodies (nAB), when ADA is positive, and the evaluation of the potential interference of ADA on ficlatuzumab-HGF binding, 8. Change from baseline in the European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-Head and Neck Module 35 (H&N35) • Time to clinically meaningful deterioration in scores on the EORTC H&N35 • Change from baseline in overall health status per the EuroQol-5 dimensions-3 level (EQ-5D-3L)
Interventions
DRUGErbitux 5 mg/mL solution for infusion
DRUGThe corresponding placebo for this study is 0.9% Sodium Chloride injection for intravenous administration and this will be provided by the study site (and reimbursed by the Sponsor).
DRUGFiclatuzumab
Sponsors
Aveo Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS), defined as the time from the date of randomization to the date of death for any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival (PFS), defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by the Investigator, or death from any cause, whichever occurs first, 2. Objective response rate (ORR), defined as the percentage of participants who have a complete response (CR) or a partial response (PR) per RECIST v1.1 as assessed by the Investigator, 3. Disease control rate (DCR), defined as the percentage of participants who have achieved a CR, PR, or stable disease (SD) for at least 8 weeks per RECIST v1.1 (as assessed by the Investigator), 4. Duration of response (DOR), defined for participants who have a confirmed CR or PR as the time from the date of first documented response (which is subsequently confirmed) per RECIST v1.1, as assessed by the Investigator, until date of documented PD or death due to any cause, whichever occurs first, 5. Incidence and severity of adv | — |
Countries
Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain
Outcome results
None listed