drugset / Trial / NCT01911325
Phase II Study of Buparlisib + Docetaxel in Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multi-center, open-label Phase Ib dose escalation part followed by a randomized double-blinded placebo controlled Phase II part. The Phase Ib part will determine the Maximum Tolerated Dose (MTD)/Recommended Phase II Dose (RP2D) of buparlisib in combination with docetaxel. Subsequently the MTD/RP2D will be investigated in a Phase II randomized trial in patients with advanced or metastatic squamous NSCLC.
Timeline
- Start
- 2013-10
- Primary completion
- 2015-08
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buparlisib | Small molecule | 80 mg | Oral |
| Subject | Buparlisib | Small molecule | 100 mg | Oral |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |