At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 106 enrolled
Drug / intervention
LEE011drug
Likely dose
LEE011 200 mgfrom 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.
Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 8 - LEE011 for Patients With CDK4/6 Pathway Activated Tumors
In Brief
A Phase 2 clinical trial evaluating LEE011 for Tumors With CDK4/6 Pathway Activation. Completed, enrolled 106 participants across 61 sites.
Detailed Summary
The purpose of this signal seeking study was to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTumors With CDK4/6 Pathway Activation
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartAug 2014
Primary CompletionJan 2018
TodayJul 2026
First PostedJul 11, 2014
Enrollment StartAug 25, 2014
Primary CompletionJan 17, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12.0 years ago
Interventions
LEE011drug
Study drug was provided in 200 mg and 50 mg hard gelatin capsules to be taken orally