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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03884829
Recruitment Status : Unknown
Verified October 2018 by Cyclacel Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
First Posted : March 21, 2019
Last Update Posted : April 5, 2019
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 28, 2018
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date April 5, 2019
Actual Study Start Date  ICMJE March 25, 2019
Estimated Primary Completion Date October 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
Number of Patients who experience dose -limiting toxicity (DLT) [ Time Frame: At end of cycle 1 (each cycle is 21 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 19, 2019)
Anti-tumor activity [ Time Frame: First dose of CYC140 to 4 weeks after the last dose of CYC140 ]
complete remission, partial remission
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS
Official Title  ICMJE A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients With Advanced Leukemias or Myelodysplastic Syndromes
Brief Summary A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
One to three patients will be entered at a given dose level of CYC140. During the first cycle, all patients will be evaluated for DLTs. If DLT occurs, additional patients (up to 3) will be dosed at that dose. If no additional DLTs observed, dose escalation will continue per protocol. If a DLT does occur, dose escalation will be stopped. At least 6 patients will be treated at the RD to confirm its tolerability.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • AML, Adult
  • Myelodysplastic Syndromes
  • ALL, Adult
  • CML, Refractory
  • CLL, Refractory
Intervention  ICMJE Drug: CYC140
CYC140 single agent
Study Arms  ICMJE Experimental: CYC140 single agent
CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle
Intervention: Drug: CYC140
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 19, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date October 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03884829
Other Study ID Numbers  ICMJE CYC140-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cyclacel Pharmaceuticals, Inc.
Study Sponsor  ICMJE Cyclacel Pharmaceuticals, Inc.
Collaborators  ICMJE M.D. Anderson Cancer Center
Investigators  ICMJE
Principal Investigator: Gautam Borthakur, MD M.D. Anderson Cancer Center
PRS Account Cyclacel Pharmaceuticals, Inc.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP