At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
LEE011 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression
In Brief
A Phase 2 clinical trial evaluating LEE011 and LEE011 Placebo for Teratoma. Completed, enrolled 10 participants across 7 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTeratoma
CountriesFrance, Netherlands, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartFeb 2015
Primary CompletionFeb 2018
TodayJul 2026
First PostedNov 25, 2014
Enrollment StartFeb 26, 2015
Primary CompletionFeb 21, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.6 years ago
Interventions
LEE011drug
LEE011 Placebodrug