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A Study of Abemaciclib in Recurrent Glioblastoma

StatusActive, Not Recruiting
PhasePhase 2
Started2017-02-09
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
Study Status, Sponsor/Collaborators, Contacts/Locations v27
Completion pushed: 2026-06-30 → 2027-06-30
2025-08-28
Study Status, Outcome Measures, Outcome Measures (Results) v26
Results first postednot stated→2025-09-02
2025-08-12
Study Status, Outcome Measures, Outcome Measures (Results) v25
Completion date2025-06-30→2026-06-30
Secondary endpointsdetails revised at 4 of 7 entries
2025-06-24
2 amendments v23-v24
2 re-verifications since 2025-06-06, no change to tracked fields
2025-05-21
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v22
Secondary endpoints7 entries, revised
pRB expressionExpression levelLevel of tumorTumor tissueTissue Area underUnder the plasmaPlasma concentrationConcentration versusVersus timeTime curveCurve (AUC)
Primary endpoints2 entries, revised
Intratumoral abemaciclibAbemaciclib concentrationConcentration
Show 21 earlier versions
2024-07-15
Study Status v21
Primary completion dateestimated 2024-06→confirmed 2024-06-30
Completion date2025-06→2025-06-30
2023-07-24
Study Status v20
Primary completion date2023-06→2024-06
Completion date2024-06→2025-06
2022-12-28
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v19
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 42→confirmed 45
Study sitesdetails revised at 7 of 7 sites
2022-07-05
Study Status v18
Primary completion date2022-06→2023-06
2021-07-29
Study Status, Eligibility, Contacts/Locations v17
Eligibility criteria+44 characters
[...] view to histologically confirm the diagnosis of glioblastoma, IDH-wildtype; glioblastoma variants; or variantsastrocytoma, IDH-mutant, WHO grade 4 (1 unstained slide or 1 H&E slide must be submitted to and [...] nrollment of the participant for central pathology review). Participants will not be eligible if the prior diagnosis was low-grade glioma and a subsequent histological diagnosis of glioblastoma or variants was made (e.g. secondary GBM). To be eligible for the study all participants (Cohort 1 and [...] so will be considered eligible for study (any copy status). OR CDK4 or CDK6 high-level amplificat [...] [...]
Study sitesdetails revised at 3 of 7 sites
2021-06-07
Active, Not Recruiting→Recruiting Study Identification, Study Status, Study Description, Arms and Interventions, Contacts/Locations v16
Trial statusActive, Not Recruiting→Recruiting
Study arms2→3
Study description+64 characters
This research study is a Phase 0/II clinical trial. Phase 0 clinical trials use only a few small doses of a drug. Phase II clinical trials test the safety and effectiveness o [...]
Study sitesdetails revised at 7 of 7 sites
2020-06-24
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v15
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 7 of 7 sites
2020-06-01
Study Status v14
Primary completion date2020-04→2022-06
Completion date2022-04→2024-06
2020-03-20
Active, Not Recruiting→Recruiting Study Status, Arms and Interventions, Eligibility, Contacts/Locations v13
Trial statusActive, Not Recruiting→Recruiting
Eligibility criteria+758 characters
[...] tus (KPS) ≥ 60 Participants must be able to swallow capsules/tablets Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy of the trial are eligible. Nature of illness and treatment history Participants must [...] profiling data from assays performed in a CLIA-certified lab. A sequencing-based assay is required and must include reporting of the RB1 gene in explicit terms within the report. Only sequencing assays that demonstrateinclude coverage of all exons of the RB1 gene are able to be utilized (mo [...] [...]
Study sitesdetails revised at 7 of 7 sites
2019-09-26
2 amendments v11-v12
2 re-verifications since 2019-05-29, no change to tracked fields
2018-12-07
Study Status, Study Design v10
Enrollment target36→42
2018-03-26
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 47→confirmed 36
Study sitesdetails revised at 7 of 7 sites
2018-01-17
Study Status v8
Completion date2024-04→2022-04
2017-06-27
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 7 sites
2017-06-26
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 7 sites
2017-06-05
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 7 sites
2017-05-30
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 7 sites
2017-03-27
Study Status, Contacts/Locations v3
Study sitesdetails revised at 2 of 7 sites
2017-02-09
Study Status, Oversight, Arms and Interventions v2
Start date2017-01→2017-02-09
2017-01-31
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2016-12→2017-01
Study sites2→7
2016-12-01
Original filing
This research study is studying a targeted therapy as a possible treatment for recurrent glioblastoma (GBM). The following intervention will be used in this study: -Abemaciclib
Trial Details
NCT Number NCT02981940
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Eli Lilly and Company
Conditions Glioblastoma
Enrollment 45 participants
Start Date 2017-02-09
Primary Completion 2024-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-04