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NCT01068483 · ClinicalTrials.gov registry record · Phase 1
Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients
A Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
- 5
- Study locations
NCT01068483: Completed Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by Novartis Pharmaceuticals.
NCT01068483 is a Phase 1 study of Breast Cancer and Ovarian Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 107 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01068483, a Phase 1 study of Breast Cancer and Ovarian Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
- 5
- Study locations
Study 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 Studied
Interventions
- DRUG BKM120
Study Locations (5)
Other
- Novartis Investigative Site - Rotterdam
- Novartis Investigative Site - Rotterdam
Tennessee
- Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4) - Nashville
Ontario
- Novartis Investigative Site - Toronto
Catalonia
- Novartis Investigative Site - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2008-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT01068483 record still lists
NCT01068483 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which BKM120 is the first listed.
NCT01068483 lists 5 locations in 4 states (Other, Tennessee, Ontario).
Frequently Asked Questions
What is clinical trial NCT01068483 about?
NCT01068483 is a clinical study titled "Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients". 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 wil...
What is the current status of trial NCT01068483?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2008-11. Estimated completion is 2012-08.
What conditions does trial NCT01068483 study?
This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer, Colon Cancer, Endometrium Cancer.
What interventions are being tested in trial NCT01068483?
The interventions under investigation include: BKM120 (DRUG).
Who is sponsoring clinical trial NCT01068483?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01068483 being conducted?
This trial has 5 study locations across Tennessee, Ontario, Catalonia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01068483's enrollment target sits among peer trials
107 547th of 1224 higher than 677 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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