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

Cyclacel Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: CML, Refractory; CLL, Refractory; AML, Adult; ALL, Adult; Myelodysplastic Syndromes

Treatments: Drug: CYC140

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03884829

CYC140-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

CYC140 single agent

Experimental group

Description:

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

Treatment:

Drug: CYC140