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NCT01473901 · ClinicalTrials.gov registry record · Phase 1
A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01473901: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01473901 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01473901, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This clinical study will assess the doses of BKM120 appropriate for patients with newly diagnosed glioblastoma when given in combination with radiotherapy and temozolomide.
Primary Outcome
Per DLT criteria as defined in protocol
Interventions
- DRUG BKM120 + temozolomide
- DRUG BKM120 +temozolomide with/without radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2011-12-30 |
| Est. Completion | 2017-05-17 |
| Phase | Phase 1 |
What the finished NCT01473901 record still lists
NCT01473901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which BKM120 + temozolomide is the first listed.
NCT01473901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01473901 about?
NCT01473901 is a clinical study titled "A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma". This clinical study will assess the doses of BKM120 appropriate for patients with newly diagnosed glioblastoma when given in combination with radiotherapy and temozolomide.
What is the current status of trial NCT01473901?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2011-12-30. Estimated completion is 2017-05-17.
What interventions are being tested in trial NCT01473901?
The interventions under investigation include: BKM120 + temozolomide (DRUG), BKM120 +temozolomide with/without radiotherapy (DRUG).
Who is sponsoring clinical trial NCT01473901?
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 NCT01473901's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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