LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
NCT02187783 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2019-07-18
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.
Conditions
- Tumors With CDK4/6 Pathway Activation
Interventions
- DRUG
-
LEE011
Study drug was provided in 200 mg and 50 mg hard gelatin capsules to be taken orally
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-25
- Primary Completion
- 2018-01-17
- Completion
- 2018-01-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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