Trials / Completed
CompletedNCT01289041
BKM120 as Second-line Therapy for Advanced Endometrial Cancer
A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BKM120 |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2011-02-03
- Last updated
- 2019-05-30
- Results posted
- 2015-04-10
Locations
42 sites across 13 countries: United States, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Japan, Poland, Russia, Singapore, Spain
Source: ClinicalTrials.gov record NCT01289041. Inclusion in this directory is not an endorsement.