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CDK Inhibitor

CYC065 for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Gautam Borthakur, MD

Research Sponsored by Cyclacel Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first dose of cyc065 to 4 weeks after the last dose of cyc065

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat relapsed or refractory AML or MDS.

Eligible Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dose of cyc065 to 4 weeks after the last dose of cyc065

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dose of cyc065 to 4 weeks after the last dose of cyc065

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose of cyc065 to 4 weeks after the last dose of cyc065 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD)

Secondary outcome measures

Pharmacodynamic effect

Pharmacokinetic effect

Other outcome measures

Anti-tumor activity

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

Neutrophil count decreased

11%

Blood creatinine increased

11%

Hypokalaemia

11%

Dermatitis

11%

Pneumonia pseudomonal

11%

Rhinovirus infection

11%

White blood cell count decreased

11%

Pneumonia

11%

Abdominal pain

11%

Anaemia

11%

Sepsis

11%

Gastroenteritis

11%

SARS-CoV-2 test positive

11%

Electrocardiogram QT prolonged

11%

Febrile neutropenia

11%

COVID-19

11%

Supraventricular tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Trial Design

1Treatment groups

Experimental Treatment

Group I: CYC065 and venetoclaxExperimental Treatment2 Interventions

CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15. Venetoclax will be taken daily on Day 1 through Day 15. One cycle will be 28 days or 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CYC065

2019

Completed Phase 1

~80

Venetoclax

2019

Completed Phase 3

~1990

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cyclacel Pharmaceuticals, Inc.Lead Sponsor

19 Previous Clinical Trials

2,465 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,972 Previous Clinical Trials

1,787,285 Total Patients Enrolled

Gautam Borthakur, MDPrincipal InvestigatorM.D. Anderson Cancer Center

6 Previous Clinical Trials

215 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has CYC065 been researched in any additional studies?

"Currently, 222 medical studies are investigating the potential of CYC065. 28 of these live trials have progressed to a Phase 3 stage. Boston, Massachusetts is hosting many of those clinical trails but there are other 7205 locations around the world also running tests with this drug."

Answered by AI

What potential risks does CYC065 pose to human health?

"The safety of CYC065 is tentatively rated at 1, since this clinical trial belongs to Phase 1 and has limited evidence backing up its efficacy and security."

Answered by AI

Are there any participant slots open for this research endeavor?

"As cited on clinicaltrials.gov, this study is no longer in need of participants. The original post was made on August 2nd 2019 and the trial ended with an edit to its details on April 22nd 2022. Although the trial has been concluded, there are still 993 other trials that require recruits at present time."

Answered by AI

What is the aggregate figure of participants who have enrolled in this investigation?

"At this time, enrollment for the trial has been suspended. It was initially listed on August 2nd 2019 and its status was most recently updated April 22nd 2022. There are currently 771 medical studies recruiting patients with myelodysplastic syndromes, while 222 trials accept participants taking CYC065."

Answered by AI

Recent research and studies

Plos OneJournal

Fadraciclib (CYC065), a Novel CDK Inhibitor, Targets Key Pro-survival and Oncogenic Pathways in Cancer

Frame, Sheelagh, Chiara Saladino, Craig MacKay, Butrus Atrash, Peter Sheldrake, Edward McDonald, Paul A. Clarke, Paul Workman, David Blake, and Daniella Zheleva. 2020. “Fadraciclib (CYC065), a Novel CDK Inhibitor, Targets Key Pro-survival and Oncogenic Pathways in Cancer”. Edited by Jed N. Lampe. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0234103.

clinicaltrials.govStudy

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS

2019. "CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04017546.