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NCT01833169 · ClinicalTrials.gov registry record · Phase 2
BKM120 for Patients With PI3K-activated Tumors
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 146
- Enrollment target
NCT01833169: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01833169 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 146 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01833169, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 146 participants
- Enrollment target
Study 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.
Primary Outcome
Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at \>=16 weeks. For hematologic tumors other appropriate hematological response criteria was applied. Response criteria: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm., PR=At least a 30% decrease in the sum of dia
Interventions
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2013-03-29 |
| Est. Completion | 2016-09-26 |
| Phase | Phase 2 |
What the finished NCT01833169 record still lists
NCT01833169 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 1 intervention - of which BKM120 is the first listed.
NCT01833169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01833169 about?
NCT01833169 is a clinical study titled "BKM120 for Patients With PI3K-activated Tumors". 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.
What is the current status of trial NCT01833169?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2013-03-29. Estimated completion is 2016-09-26.
What interventions are being tested in trial NCT01833169?
The interventions under investigation include: BKM120 (DRUG).
Who is sponsoring clinical trial NCT01833169?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01833169's enrollment target sits among peer trials
146 496th of 2000 higher than 1,503 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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