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NCT01343498 · ClinicalTrials.gov registry record · Phase 1
Study of PI3 Kinase/mTOR Inhibitor BEZ235 Twice Daily for Advanced Solid Tumors
A Phase 1 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01343498: Completed Phase 1 study, sponsored by SCRI Development Innovations.
NCT01343498 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01343498, a Phase 1 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This is a dose escalation trial to evaluate twice daily dosing of the sachet formulation of BEZ235. This trial will find the maximum tolerated dose (MTD) of the sachet formulation given twice daily, as well as evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of the twice daily dosing. Patients will initially be given once daily dosing to determine the PK and PD of the single daily dose. On Day 9, they will begin twice daily dosing, with half of the single daily dose divided twice daily, and PK and PD of the twice daily dose will be determined.
Primary Outcome
To determine the maximum tolerated dose (MTD) of BEZ235 given twice daily in patients with advanced solid tumors
Interventions
- DRUG BEZ235
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT01343498 record still lists
NCT01343498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which BEZ235 is the first listed.
NCT01343498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01343498 about?
NCT01343498 is a clinical study titled "Study of PI3 Kinase/mTOR Inhibitor BEZ235 Twice Daily for Advanced Solid Tumors". This is a dose escalation trial to evaluate twice daily dosing of the sachet formulation of BEZ235. This trial will find the maximum tolerated dose (MTD) of the sachet formulation given twice daily, as well as evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of the twice daily dosing. Patien...
What is the current status of trial NCT01343498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2011-04. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01343498?
The interventions under investigation include: BEZ235 (DRUG).
Who is sponsoring clinical trial NCT01343498?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01343498's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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