Description:
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
Unknown status
Phase 1
Drug | Synonyms | Arms |
---|---|---|
CYC140 | CYC140 single agent |
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.
Name | Type | Description | Interventions |
---|---|---|---|
CYC140 single agent | Experimental | CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle |
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Number of Patients who experience dose -limiting toxicity (DLT) |
Time Frame: | At end of cycle 1 (each cycle is 21 days) |
Safety Issue: | |
Description: |
Measure: | Pharmacokinetic measurement - area under the curve (AUC) |
Time Frame: | At the end of cycle 1 (each cycle is 21 days) |
Safety Issue: | |
Description: | plasma drug exposure area under the curve (AUC) |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Cyclacel Pharmaceuticals, Inc. |
April 5, 2019