Trials / Terminated
TerminatedNCT01911325
Phase II Study of Buparlisib + Docetaxel in Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) Patients
A Phase Ib/II Study of Docetaxel With or Without Buparlisib as Second Line Therapy for Patients With Advanced or Metastatic Squamous Non-small Cell Lung Cancer
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Based on an overall review of safety and preliminary efficacy data done on 01-Dec-2014 showing marginal anti-tumor activity and newly emerged treatment options, a decision was taken to stop further development of this combination in patients with advanced or metastatic squamous NSCLC and Phase II of the study was not conducted.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Buparlisib | |
| DRUG | Buparlisib matching placebo | |
| DRUG | Docetaxel |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2013-07-30
- Last updated
- 2018-08-14
Locations
16 sites across 8 countries: United States, Belgium, France, Germany, Italy, South Korea, Spain, Sweden
Source: ClinicalTrials.gov record NCT01911325. Inclusion in this directory is not an endorsement.