drugset / Trial / NCT01721525
Induction Chemotherapy With Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)
Phase 1
Completed
10 enrolled
Memorial Sloan Kettering Cancer Center
Boehringer Ingelheim · collabNational Comprehensive Cancer Network · collab
NaSingle-groupOpen-labelTreatment
Summary
This study seeks to develop a new induction chemotherapy regimen which is a combination of two pill drugs taken by mouth and two drugs given by vein. This is a phase I study, which means that the primary goal is to establish the recommended dose of an investigational drug when added to chemotherapy. The researchers wish to evaluate the effects, good and bad, of the investigational drug.
Timeline
- Start
- 2012-11
- Primary completion
- 2017-10-16
- Completion
- 2017-10-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | 30 mg | Oral |
| Subject | Afatinib | Small molecule | 40 mg | Oral |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Background | Ribavirin | Small molecule | 1000 mg | Oral |
| Background | Ribavirin | Small molecule | 1200 mg | Oral |