At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 70 enrolled
Drug / intervention
BKM120drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma
In Brief
A Phase 2 clinical trial evaluating BKM120 for Advanced Endometrial Cancer. Completed, enrolled 70 participants across 42 sites in 13 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Endometrial Cancer
CountriesAustralia, Belgium, Brazil, Canada, France, Germany, Italy, Japan, Poland, Russia, Singapore, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedFeb 2011
Primary CompletionMar 2014
TodayJul 2026
First PostedFeb 3, 2011
Enrollment StartFeb 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.4 years ago
Interventions
BKM120drug