Ribociclib in Sequential Combination with Doxorubicin in Anthracycline-Naive Advanced Soft-Tissue Sarcomas: Results of a Dose-Finding Phase Ib Study.

ABSTRACT:

Purpose

Doxorubicin is the first-line treatment for metastatic soft-tissue sarcomas. Ribociclib, a cyclin-dependent kinase 4/6 intargets the retinoblastoma pathway to induce cell-cycle arrest at the G1-S cell-cycle checkpoint. We hypothesized that administering ribociclib prior to doxorubicin to synchronize cell-cycle progression among tumor cells may enhance the efficacy of doxorubicin.

Patients and methods

Doxorubicin-naïve patients with metastatic soft-tissue sarcoma were enrolled in this phase Ib study. Every 21 days, subjects received ribociclib daily for 7 days followed by 3 days of no treatment before administration of doxorubicin. The primary objective was to establish the recommended phase II dose of the sequenced drug combination. Secondary objectives included prog

SUBMITTER: Davis LE 

PROVIDER: S-EPMC12213156 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature