Symptoms and General Pathology

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Hematologic Diseases

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Phase 1 = fadraciclib administered orally in escalating doses starting at 50mg bid MWF for 3 weeks of a 4-week cycle. Subsequent cohorts will escalate in dose and schedule until optimized phase 2 dose and schedule is achieved.

Recommended fadraciclib phase 2 dose and schedule administered orally in 28-day cycles.

Fadraciclib is a highly selective, orally- and intravenously- available, 2nd generation amino-purine inhibitor of CDK2 and CDK9.

fadraciclib

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.

Phase 1 part of the study will consist of a dose-escalation and a dose-finding component.

Phase 2 will enroll subjects AML, CLL, or MDS, into 7 groups:

Group 1: Subjects with AML or MDS having marrow blasts over \> 10%, who have experienced an inadequate response or progression on venetoclax combinations with either HMAs or low dose Ara-C or similar venetoclax combinations

Group 2: Fadraciclib: Subjects with AML or MDS relapsed/refractory having marrow blasts over \> 10% with FLT3, KIT, MAPK pathway (N and K RAS, BRAF, PTPN11, NF1) mutations after at least 1 line of prior therapy.

Group 3: Fadraciclib: Subjects with CLL who have progressed on 2 or more lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and venetoclax.

Group 4: Fadraciclib plus azacitidine: Subjects with AML or MDS who have progressed after therapy with an HMA.

Group 5: Fadraciclib plus venetoclax: Subjects with AML or MDS who have progressed after therapy with venetoclax.

Group 6: Fadraciclib plus venetoclax: Subjects with CLL or small lymphocytic lymphoma (SLL) who have progressed after therapy with venetoclax.

Group 7: Basket cohort: Leukemia types suspected to have a related mechanism of action such as MCL1, or MYC amplification/over-expression not included in previous groups

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

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)

To investigate CDK9-dependent transcription inhibition as assessed by differential target gene expression relative to baseline.

To investigate plasma cell-free DNA mutation and copy number variation profile of fadraciclib as determined by NGS.

To investigate effect on epigenetics, immunomodulation and apoptotic pathway

The incidence rate of dose-limiting toxicities (first cycle only) at each dose level

Assessment of response criteria according to iwCLL criteria for CLL/SLL and IWG criteria for AML and MDS.

Type, frequency, and severity of adverse drug reactions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Investigate Fadraciclib (CYC065), in Subjects With Leukemia or Myelodysplastic Syndrome (MDS)	NCT05168904	Leukemia Myelodysplastic...	fadraciclib	18 Years -	Cyclacel Pharmaceuticals, Inc.
A Study to Investigate Fadraciclib (CYC065), in Subjects With Leukemia or Myelodysplastic Syndrome (MDS)	NCT05168904	Leukemia Myelodysplastic...	fadraciclib	18 Years -	Cyclacel Pharmaceuticals, Inc.
A Study to Investigate Fadraciclib (CYC065), in Subjects With Leukemia or Myelodysplastic Syndrome (MDS)	NCT05168904	Leukemia Myelodysplastic...	fadraciclib	18 Years -	Cyclacel Pharmaceuticals, Inc.
A Study to Investigate Fadraciclib (CYC065), in Subjects With Leukemia or Myelodysplastic Syndrome (MDS)	NCT05168904	Leukemia Myelodysplastic...	fadraciclib	18 Years -	Cyclacel Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for fadraciclib

Every month we try and update this database with for fadraciclib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fadraciclib

Every month we try and update this database with for fadraciclib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fadraciclib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.