ALL, Adult, AML, Adult, CLL, Refractory, CML, Refractory, Myelodysplastic Syndromes
Conditions
Keywords
AML, ALL, CLL, CML, MDS, advanced leukemias, leukemia
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.
Interventions
DRUGCYC140
CYC140 single agent
Sponsors
M.D. Anderson Cancer Center
Cyclacel Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One to three patients will be entered at a given dose level of CYC140. During the first cycle, all patients will be evaluated for DLTs. If DLT occurs, additional patients (up to 3) will be dosed at that dose. If no additional DLTs observed, dose escalation will continue per protocol. If a DLT does occur, dose escalation will be stopped. At least 6 patients will be treated at the RD to confirm its tolerability.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients who experience dose -limiting toxicity (DLT) | At end of cycle 1 (each cycle is 21 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anti-tumor activity | First dose of CYC140 to 4 weeks after the last dose of CYC140 | complete remission, partial remission |
Countries
United States
Outcome results
None listed