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Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6

StatusRecruiting
PhasePhase 2
Started2017-11-21
View on ClinicalTrials.gov ↗

Amendment history

2026-04-24
minor
Study Status, Oversight, Outcome Measures v16
Primary completion date2026-04-01→2027-01-01
Completion date2026-09-30→2027-09-30
Secondary endpoints2 entries, revised
ToxicityAdverse events by CTCAE 4.03
2025-08-26
minor
Study Identification, Study Status, Oversight v15
Primary completion date2025-09-01→2026-04-01
Completion date2026-04-30→2026-09-30
Study titlerevised
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-typeType Cyclins or Amplification of CDK4 or CDK6
2025-01-23
minor
Study Status v14
Primary completion date2024-12-31→2025-09-01
Completion date2025-04-30→2026-04-30
2024-02-02
minor
Study Status, Contacts/Locations v13
Primary completion date2024-06-01→2024-12-31
2023-07-09
minor
Study Status v12
Primary completion date2023-06-01→2024-06-01
Show 11 earlier versions
2023-01-09
minor
Study Status v11
Re-verified, no change to tracked fields
2022-01-18
minor
Study Status v10
Primary completion date2022-06-01→2023-06-01
2021-06-01
minor
Study Status v9
Primary completion date2021-04-30→2022-06-01
2020-12-01
minor
6 amendments v3-v8
6 re-verifications since 2018-06-29, no change to tracked fields
2017-11-30
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2017-11-15→confirmed 2017-11-21
Study sitesdetails revised at 1 of 1 site
2017-11-02
minor
Study Identification, Study Status, Outcome Measures v1
Start date2017-10-31→2017-11-15
Secondary endpointsdetails revised at 2 of 2 entries
Study title-25 characters
A Phase II Study of the CDK4/6 Inhibitor Abemaciclib in Patients With Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6
2017-10-11
minor
Original filing
This research study is studying a targeted therapy as a possible treatment for cancer abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6. The drug involved in this study is: -Abemaciclib
Trial Details
NCT Number NCT03310879
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Eli Lilly and Company
Conditions Cancer
Enrollment 38 participants
Start Date 2017-11-21
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-29