OncoMatch/Clinical Trials/NCT03310879
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
Is NCT03310879 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Abemaciclib for cancer.
Treatment: Abemaciclib — 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
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CCND1 high-level amplification
Required: CCND1 mutation
Required: CCND1 splice variant expected to lead to nuclear retention of cyclin d1 protein
Required: CCND2 high-level amplification
Required: CCND3 high-level amplification
Required: CDK4 high-level amplification
Required: CDK6 high-level amplification
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: cdk4/6 inhibitor
Lab requirements
Blood counts
Absolute neutrophil count ≥1,500/mcL; Platelets ≥100,000/mcL
Kidney function
Serum Creatinine ≤ 1.5 × institutional ULN or Creatinine clearance ≥ 60 mL/min (Cockroft-Gault Equation)
Liver function
Total bilirubin ≤ 1.5 × institutional ULN; AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN or ≤ 5 × ULN if liver metastases are present
Participants must have normal organ and marrow function as defined below: * Absolute neutrophil count ≥1,500/mcL * Platelets ≥100,000/mcL * Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional (ULN) -OR- * AST(SGOT)/ALT(SGPT) ≤ 5 × institutional (ULN) if liver metastases are present * Serum Creatinine ≤ 1.5 × institutional ULN -OR- * Creatinine clearance ≥ 60 mL/min (Cockroft-Gault Equation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana Farber Cancer Institute · Boston, Massachusetts
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