CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS
- Registration Number
- NCT04017546
- Lead Sponsor
- Cyclacel Pharmaceuticals, Inc.
- Brief Summary
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS
- Detailed Description
This is an open-label, single arm, dose escalation study in patients with relapsed or refractory AML or MDS. Treatment will be administered on an outpatient basis and all patients will receive CYC065 over 4-hour infusion once every 2 weeks on Day 1 and Day 15 in combination with venetoclax. One treatment cycle is 4 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Previously treated AML or MDS based on WHO classification and having at least 10% blasts in peripheral blood
- ECOG 0-2
- Adequate renal function
- Adequate liver function
- INR <=1.2 in patients not receiving chronic anticoagulation
- At least 2 weeks from prior cytotoxic chemotherapy, radiation therapy, major surgery or other investigational cancer therapy
- Agree to practice effective contraception
Exclusion Criteria
- AML is of the subtype of APL or extramedullary myeloid tumor without bone marrow involvment
- Known AML involvement in CNS that is symptomatic and active
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CYC065 and venetoclax CYC065 CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15. Venetoclax will be taken daily on Day 1 through Day 15. One cycle will be 28 days or 4 weeks. CYC065 and venetoclax Venetoclax CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15. Venetoclax will be taken daily on Day 1 through Day 15. One cycle will be 28 days or 4 weeks.
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) At the end of cycle 1 (each cycle is 28 days) Number of patients who experience dose-limiting toxicity (DLT)
- Secondary Outcome Measures
Name Time Method Pharmacodynamic effect At the end of cycle 1 (each cycle is 28 days) MCL-1 level in peripheral white blood cells
Pharmacokinetic effect At the end of cycle 1 (each cycle is 28 days) plasma drug level
Trial Locations
- Locations (1)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States