At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 146 enrolled
Drug / intervention
BKM120drug
Likely dose
BKM120 100 mgfrom 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.
Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 1 - BKM120 for Patients With PI3K-activated Tumors
In Brief
A Phase 2 clinical trial evaluating BKM120 for PI3K Pathway Activated Tumors. Completed, enrolled 146 participants across 59 sites.
Detailed Summary
The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPI3K Pathway Activated Tumors
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2013
First PostedApr 2013
Primary CompletionSep 2016
TodayJul 2026
First PostedApr 16, 2013
Enrollment StartMar 29, 2013
Primary CompletionSep 26, 2016
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.2 years ago
Interventions
BKM120drug
BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28-day cycle