Clinical Trials /

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

NCT03884829

Description:

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

Related Conditions:
  • Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Unknown status

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT03884829

Trial Eligibility

Document

Title

  • Brief Title: A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS
  • Official Title: A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients With Advanced Leukemias or Myelodysplastic Syndromes

Clinical Trial IDs

  • ORG STUDY ID: CYC140-01
  • NCT ID: NCT03884829

Conditions

  • AML, Adult
  • Myelodysplastic Syndromes
  • ALL, Adult
  • CML, Refractory
  • CLL, Refractory

Interventions

DrugSynonymsArms
CYC140CYC140 single agent

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
CYC140 single agentExperimentalCYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle
  • CYC140

Eligibility 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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Cyclacel Pharmaceuticals, Inc.

Trial Keywords

  • AML, ALL, CLL, CML, MDS, advanced leukemias, leukemia

Last Updated

April 5, 2019