Trial reportTargeted oncology2026
Phase I/II Study of the CDK2/9 Inhibitor Fadraciclib in Combination with Chemotherapy in Children with Advanced Malignancies: Arm K of the AcSé-ESMART Trial.
Trial report in Targeted oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
13 authors.
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Abstract
backgroundCyclin-dependent kinase (CDK) dysregulation is common in pediatric cancers. The dual CDK2/9 inhibitor fadraciclib has shown preclinical antitumor activity, alone and in combination, supporting clinical evaluation in children.
objectiveArm K of the AcSé-ESMART proof-of-concept phase I/II platform trial aimed to define the recommended phase II dose (RP2D), pharmacokinetics, antitumor activity and predictive biomarker(s) of fadraciclib in combination with temozolomide in pediatric patients with recurrent/refractory solid malignancies. PATIENTS AND
methodsFadraciclib was administered intravenously once on Day 1 ± Day 15, and temozolomide orally on Days 1-5. Dose escalation of fadraciclib followed the continuous reassessment method starting at 135 mg/m
resultsTwelve patients were enrolled and treated (median age: 12.1 years, range 4.0-17.9). Main diagnoses were sarcoma and central nervous system tumors. Dose-limiting toxicities and main treatment-related adverse events were hematologic. The final tolerated intravenous fadraciclib dose could be estimated at 135 mg/m
conclusionsThis pediatric study was the first to explore the CDK2/9 inhibitor fadraciclib. Fadraciclib combined with temozolomide showed a manageable safety profile with limited clinical activity. TRIAL REGISTRY: ClinicalTrials.gov NCT2813135. Registered on: 24 June 2016.
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