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NCT01747876 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01747876 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 32 participants.
The verdict
NCT01747876, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo activity in both tumor models. The primary purpose of this study was to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in pediatric patients and to delineate a clinical dose to be used in future studies. This study was also to have assessed the safety, tolerability, PK and preliminary evidence of antitumor activity of LEE011 in patients with MRT or neuroblastoma.
Interventions
- DRUG LEE011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-05-28 |
| Est. Completion | 2017-06-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01747876
The ClinicalTrials.gov registry entry for NCT01747876 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LEE011 is the first listed.
NCT01747876 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01747876 about?
NCT01747876 is a clinical study titled "Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma". LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo activity in both tumor models. The primary purpose of this study was to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in pediatric patients and to delineate a clinica...
What is the current status of trial NCT01747876?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2013-05-28. Estimated completion is 2017-06-29.
What interventions are being tested in trial NCT01747876?
The interventions under investigation include: LEE011 (DRUG).
Who is sponsoring clinical trial NCT01747876?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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