Trial Profile

A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety and Efficacy of Fadraciclib (CYC065), an Oral CDK 2/9 Inhibitor, in Subjects With Leukemias or Myelodysplastic Syndrome (MDS)

Status: Suspended

Phase of Trial: Phase I/II

Latest Information Update: 13 Feb 2024

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At a glance

Drugs Fadraciclib (Primary)
Indications Chronic lymphocytic leukaemia; Leukaemia; Myelodysplastic syndromes
Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
Sponsors Cyclacel Pharmaceuticals

06 Feb 2024 Status changed from recruiting to suspended (Slow enrollment and financial limitations).
09 Nov 2022 According to a Cyclacel Pharmaceuticals media release, interim data from dose escalation stage is expected in 2H 2023.
30 Jun 2022 According to a Cyclacel Pharmaceuticals media release, Based on good tolerability in 065-101, a protocol amendment to this study has enabled acceleration of the study by omitting dose levels two and three and now enrolling at dose level 4.

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