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

Myelodysplastic Syndromes Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03884829
• Other study ID #: CYC140-01
• Status: Recruiting
• Phase: Phase 1
• Start date: March 25, 2019
• Est. completion date: September 2023

Study information

• Verified date: April 2022
• Source: Cyclacel Pharmaceuticals, Inc.
• Contact: Mark Kirschbaum, MD
• Phone: 6263163394
• Email: mkirschbaum[@]cyclacel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALL, Adult
• AML, Adult
• CLL, Refractory
• CML, Refractory
• Leukemia
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• CYC140
CYC140 single agent

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Cyclacel Pharmaceuticals, Inc.	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-tumor activity	complete remission, partial remission	First dose of CYC140 to 4 weeks after the last dose of CYC140
Primary	Number of Patients who experience dose -limiting toxicity (DLT)		At end of cycle 1 (each cycle is 21 days)
Secondary	Pharmacokinetic measurement - area under the curve (AUC)	plasma drug exposure area under the curve (AUC)	At the end of cycle 1 (each cycle is 21 days)