A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | March 25, 2019 |
| End Date: | February 28, 2021 |
| Contact: | Judy Chiao, MD |
| Email: | jchiao@cyclacel.com |
| Phone: | 908.517.7330 |
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
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.
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
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