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

A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes

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.

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