A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS

September 11, 2024 updated by: Cyclacel Pharmaceuticals, Inc.

A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes

A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a First in Human, open-label, single arm, dose escalation study in patients with advanced leukemias or myelodysplastic syndromes. Patients will receive CYC140 as a 1 hr infusion once a week for 2 weeks followed by 1 week of rest on an outpatient basis. One treatment cycle is 3 weeks.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of relapsed or refractory advanced leukemias or MDS
  • ECOG 0-2
  • Adequate renal function
  • Adequate liver function
  • ≥ 2 weeks from prior chemotherapy, radiation therapy or major surgery
  • ≥ 4 weeks from other investigational anticancer therapy
  • Agree to practice effective contraception

Exclusion Criteria:

  • Known CNS involvement by leukemia
  • Currently receiving radiotherapy, biological therapy, or any other investigational agents
  • Uncontrolled intercurrent illness
  • Pregnant or lactating
  • Known to be HIV-positive
  • Known active hepatitis B and/ or hepatitis C infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CYC140 single agent
CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle
Drug: CYC140
CYC140 single agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients who experience dose -limiting toxicity (DLT)
Time Frame: At end of cycle 1 (each cycle is 21 days)
At end of cycle 1 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic measurement - area under the curve (AUC)
Time Frame: At the end of cycle 1 (each cycle is 21 days)
plasma drug exposure area under the curve (AUC)
At the end of cycle 1 (each cycle is 21 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-tumor activity
Time Frame: First dose of CYC140 to 4 weeks after the last dose of CYC140
complete remission, partial remission
First dose of CYC140 to 4 weeks after the last dose of CYC140

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyclacel Pharmaceuticals, Inc.

Collaborators

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Gautam Borthakur, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2019

Primary Completion (Actual)

November 29, 2021

Study Completion (Actual)

October 19, 2023

Study Registration Dates

First Submitted

October 28, 2018

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYC140-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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