CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS

Cyclacel Pharmaceuticals, Inc.14 enrolled

Overview

A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

AML MDS

Interventions

CYC065DRUG

intravenous infusion

VenetoclaxDRUG

oral capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Maximum tolerated dose (MTD)

Number of patients who experience dose-limiting toxicity (DLT)

Time frame: At the end of cycle 1 (each cycle is 28 days)

Secondary Outcomes

Pharmacokinetic effect

plasma drug level

Time frame: At the end of cycle 1 (each cycle is 28 days)

Pharmacodynamic effect

MCL-1 level in peripheral white blood cells

Time frame: At the end of cycle 1 (each cycle is 28 days)

Data from ClinicalTrials.gov

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