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

Phase 1

• Conditions: AML, Adult; Myelodysplastic Syndromes; CML, Refractory; CLL, Refractory; ALL, Adult
• Interventions: Drug: CYC140

• Registration Number: NCT03884829
• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.

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 Timeline

• Study First Submitted: 2018-10-28
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Study Start: 2019-03-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25
• Primary Completion: 2023-04
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Patients who experience dose -limiting toxicity (DLT)	At end of cycle 1 (each cycle is 21 days)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic measurement - area under the curve (AUC)	At the end of cycle 1 (each cycle is 21 days)	plasma drug exposure area under the curve (AUC)

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States