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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 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 33 participants.
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.
Interventions
- DRUG BEZ235
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01343498
The ClinicalTrials.gov registry entry for NCT01343498 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BEZ235 is the first listed.
NCT01343498 reports 0 study locations.
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.
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