drugset / Trial / NCT00617734
Study of IMC-A12, Alone or in Combination With Cetuximab, in Participants With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab (Erbitux®) can increase the time prior to disease progression in participants with Squamous Cell Head and Neck Cancer who have had disease progression and platinum-containing chemotherapeutic regimen.
Timeline
- Start
- 2008-03
- Primary completion
- 2012-02
- Completion
- 2012-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); IMC-A12 (Cixutumumab) vs IMC-A12 (Cixutumumab) + Cetuximab; p = 0.0667; Log Rank NCT00617734 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | — |
| Subject | Cixutumumab | Monoclonal antibody | 10 mg/kg | — |