drugset / Trial / NCT01816984
PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
NaSingle-groupOpen-labelTreatment
Summary
This pilot randomized phase I/II trial studies the side effects and best dose of PI3K inhibitor BKM120 when given together with cetuximab and to see how well it works in treating patients with recurrent or metastatic head and neck cancer. PI3K inhibitor BKM120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving PI3K inhibitor BKM120 together with cetuximab may kill more tumor cells
Timeline
- Start
- 2013-05
- Primary completion
- 2018-04
- Completion
- 2020-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buparlisib | Small molecule | 80 mg | Oral |
| Subject | Buparlisib | Small molecule | 100 mg | Oral |
| Subject | Cetuximab | Monoclonal antibody | 500 mg | Intravenous |
Indications
cancer of unknown primary site
hypopharynx squamous cell carcinoma
larynx verrucous carcinoma
metastatic squamous cell carcinoma
nasal cavity and paranasal sinus squamous cell carcinoma
nasopharyngeal squamous cell carcinoma
oropharynx squamous cell carcinoma
salivary gland squamous cell carcinoma
tongue cancer
verrucous carcinoma of oral cavity