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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884829
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
AML, Adult Myelodysplastic Syndromes ALL, Adult CML, Refractory CLL, Refractory Drug: CYC140 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients With Advanced Leukemias or Myelodysplastic Syndromes
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : October 26, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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

Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. Anti-tumor activity [ Time Frame: First dose of CYC140 to 4 weeks after the last dose of CYC140 ]
    complete remission, partial remission


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884829


Contacts
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Contact: Judy Chiao, MD 908.517.7330 jchiao@cyclacel.com

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Hind Alazzawi    713-794-4823    halazzawi@mdanderson.org   
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Gautam Borthakur, MD M.D. Anderson Cancer Center
More Information
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Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03884829    
Other Study ID Numbers: CYC140-01
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cyclacel Pharmaceuticals, Inc.:
AML, ALL, CLL, CML, MDS, advanced leukemias, leukemia
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
 Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions