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NCT02300987 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02300987 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 10 participants.
The verdict
NCT02300987, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This was a multi-center, randomized, double blind (investigator and subject), placebo controlled Phase II study to determine the efficacy and safety of treatment with ribociclib versus placebo in subjects with progressive relapsed, refractory incurable teratoma. Eligible subjects were randomized in a 2:1 ratio to ribociclib or placebo. After discontinuation of study treatment, patients were followed up for safety, disease progression and overall survival.
Interventions
- DRUG LEE011
- DRUG LEE011 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-02-26 |
| Est. Completion | 2018-02-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02300987
The ClinicalTrials.gov registry entry for NCT02300987 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 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 2 interventions - of which LEE011 is the first listed.
NCT02300987 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02300987 about?
NCT02300987 is a clinical study titled "A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression". This was a multi-center, randomized, double blind (investigator and subject), placebo controlled Phase II study to determine the efficacy and safety of treatment with ribociclib versus placebo in subjects with progressive relapsed, refractory incurable teratoma. Eligible subjects were randomized in ...
What is the current status of trial NCT02300987?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2015-02-26. Estimated completion is 2018-02-21.
What interventions are being tested in trial NCT02300987?
The interventions under investigation include: LEE011 (DRUG), LEE011 Placebo (DRUG).
Who is sponsoring clinical trial NCT02300987?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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