Trial intelligence / Profile preview

Ribociclib in Relapsed, Refractory, Incurable Teratoma

NCT02300987Phase 2

Key facts

Status: Completed
Start: Feb 2015
Primary completion: Feb 2018
Countries: 4
Sponsor: Novartis
Modality: Small Molecules

Drugs: ribociclib
Conditions: teratoma

Overview

Phase 2, randomised, double-blind trial in teratoma comparing LEE011 with Placebo (2 arms). Primary endpoint: Progression Free Survival at 24 months. Started Feb 2015; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

LEE011
Ribociclib 600 mg daily days 1-21 of 28 day cycle
Placebo
Placebo 600 mg daily days 1-21 of 28 day cycle

Who it enrols

Patients with relapsed, refractory, incurable teratoma with recent progression who have completed at least 1 prior line of chemotherapy (unless primary pure teratoma).

Endpoints

Primary

Progression Free Survival24 months

Secondary

Best Overall Response24 months
Overall Response Rate27 months
Disease Control Rate24 months
Overall Survival27 months
Overall Survival Rate27 months

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