drugset / Trial / NCT05168904

A Study to Investigate Fadraciclib (CYC065), in Subjects With Leukemia or Myelodysplastic Syndrome (MDS)

NCT05168904

Phase 1/2 Suspended 210 enrolled Cyclacel Pharmaceuticals, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety and efficacy of fadraciclib (formerly CYC065) administered orally BID. This study consists of Phase 1 and Phase 2 components in subjects with Leukemia or Myelodysplastic syndrome (MDS) who have progressed despite having standard therapy or for which no standard therapy exists.

Timeline

Start
2021-10-22
Primary completion
2024-10
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CYC065 Small molecule 50 mg Oral