A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression
Completed · Phase 2 · Has a placebo group
Conditions studied: Teratoma
In brief
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.
Key facts
- Study ID
- NCT02300987
- Run by
- Novartis Pharmaceuticals
- People needed
- 10
- Starts
- 2015-02-26
- Expected to finish
- 2018-02-21
- Last updated by the study team
- 2020-10-26
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- USC Kenneth Norris Comprehensive Cancer Center Oncology Dept — Los Angeles, California, United States
- New Mexico Cancer Care Alliance — Albuquerque, New Mexico, United States
- Memorial Sloan Kettering Oncology Department. — New York, New York, United States
- Novartis Investigative Site — Villejuif, France
- Novartis Investigative Site — Groningen, Netherlands
- Novartis Investigative Site — L'Hospitalet de Llobregat, Catalonia, Spain
- Novartis Investigative Site — Madrid, Spain
Full record on ClinicalTrials.gov
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