Description:
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS
Title
- Brief Title: CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS
- Official Title: A Phase I Combination Study of CYC065 and Venetoclax in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
Clinical Trial IDs
- ORG STUDY ID:
CYC065-03
- NCT ID:
NCT04017546
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| CYC065 | | CYC065 and venetoclax |
| Venetoclax | | CYC065 and venetoclax |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| CYC065 and venetoclax | Experimental | 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. | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Maximum tolerated dose (MTD) |
| Time Frame: | At the end of cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | Number of patients who experience dose-limiting toxicity (DLT) |
Secondary Outcome Measures
| Measure: | Pharmacokinetic effect |
| Time Frame: | At the end of cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | plasma drug level |
| Measure: | Pharmacodynamic effect |
| Time Frame: | At the end of cycle 1 (each cycle is 28 days) |
| Safety Issue: | |
| Description: | MCL-1 level in peripheral white blood cells |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Cyclacel Pharmaceuticals, Inc. |
Trial Keywords
- CYC065
- CDK2/9
- venetoclax
- BCL-2
- MCL-1
- Relapsed
- Refractory
- acute myeloid leukemia
- myelodysplastic syndromes
- AML
- MDS
Last Updated
July 12, 2019
