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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2024
  • participants needed
    210
  • sponsor
    Cyclacel Pharmaceuticals, Inc.
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Updated on 24 April 2022
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hydroxyurea
decitabine
leukemia
ara-c
azacitidine
blast cells
aml/mds

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.

Description

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

Details
Condition Leukemia, Myelodysplastic Syndrome(MDS)
Treatment Fadraciclib
Clinical Study IdentifierNCT05168904
SponsorCyclacel Pharmaceuticals, Inc.
Last Modified on24 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Males or females aged ≥ 18 years
a) AML/MDS with blasts > 10% in subjects who have had an inadequate response or progression to venetoclax combinations with either HMA or low dose Ara-C or similar venetoclax combinations. or b. CLL in subjects who have received at least 2 lines of therapy, including venetoclax and a BTK inhibitor, who require therapy as per iwCLL criteria
Any prior therapy must have been completed at least 2 weeks prior to enrollment on this protocol, and the participant must have recovered to eligibility levels from prior toxicity
Hydroxyurea may be used for the first 14 days of Cycle 1 for peripheral blast control. Valproic acid not being used for seizure control should be stopped 72 hours before starting treatment with fadraciclib
Any prior therapy with decitabine or azacitidine must have been completed at least 3 weeks prior to enrollment on this protocol
Subjects who relapsed post-autologous or post-allogeneic transplant are eligible. Post-transplant subjects must be without active fungal disease or significant acute graft-versus-host disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to receiving the first dose and for 6 months after the last dose) if conception is possible during this interval
Subjects must be able to swallow and retain orally administered medication and not have any clinically significant GI abnormalities that may alter the absorption, such as malabsorption syndrome or major resection of the stomach or bowels
Subjects must be able to agree to and sign the informed consent and to comply with the protocol

Exclusion Criteria

Subjects with known active leptomeningeal involvement by AML
Subjects who have not received vaccines for SARS-COV-2 within the last 3 months and have suspected signs and symptoms of COVID-19 or a recent history (within 14 days) of contact with any COVID-19 positive subject/isolation/quarantine or subjects with confirmed COVID-19
Subjects with a history of another primary malignancy, other than
Carcinomas in situ, e.g., breast, cervix, and prostate
Locally excised non-melanoma skin cancer
No evidence of disease from another primary cancer for 2 or more years and has not taken any anticancer treatment in 2 years
Any other clinically significant acute or chronic medical or psychiatric condition or
any laboratory abnormality that may increase the risk associated with study
drug administration or may interfere with the interpretation of study results
Diseases that significantly affect GI absorption of fadraciclib
Subjects who have impaired cardiac function or clinically significant cardiac disease
Presence of active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment
Presence of an active infection requiring IV antibiotics
Presence of known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that may interfere with metabolism
Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV)
Subject has received systemic anticancer therapy (including investigational therapy), radiotherapy, or immunotherapy < 14 days or 5 half-lives (whichever is shorter) prior to administration of Dose 1 of study drug on Day 1 or have not recovered from the side effects of such therapy
Major surgery/surgical therapy for any cause within 4 weeks of the first dose
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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