Trials / Completed
CompletedNCT01068483
Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients
A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part. Once the MTD has been defined, the MTD expansion part will be opened for enrollment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BKM120 |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2011-09-01
- Completion
- 2012-08-01
- First posted
- 2010-02-15
- Last updated
- 2020-12-08
Locations
5 sites across 4 countries: United States, Canada, Netherlands, Spain
Source: ClinicalTrials.gov record NCT01068483. Inclusion in this directory is not an endorsement.