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

Phase 1TerminatedNCT03884829

Cyclacel Pharmaceuticals, Inc.7 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

CYC140DRUG

CYC140 single agent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Patients who experience dose -limiting toxicity (DLT)

Time frame: At end of cycle 1 (each cycle is 21 days)

Secondary Outcomes

Pharmacokinetic measurement - area under the curve (AUC)

plasma drug exposure area under the curve (AUC)

Time frame: At the end of cycle 1 (each cycle is 21 days)

Data from ClinicalTrials.gov

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