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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-02

Study Completion Date

2023-04-05

Brief Summary

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

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Detailed Description

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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.

Conditions

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AML MDS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

One to 6 patients will be entered at a given CYC065 dose level. Dose escalation will be 33% after at least one patient has completed the first treatment cycle without ≥ grade 2 toxicity considered by the investigator to be related to CYC065. Upon the first occurrence of grade 2 toxicity related to CYC065, at least 3 patients will be entered at each dose level. If no DLT is observed in any patients, dose escalation will continue to be 33%. If one of 3 patients experienced a DLT at a given dose level, dose escalation will continue at 25% until MTD is reached. If 2 or more patients experienced a DLT at a given dose level, dose escalation will be stopped. At least 6 patients will be treated at MTD.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CYC065 and 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.

Group Type EXPERIMENTAL

CYC065

Intervention Type DRUG

intravenous infusion

Venetoclax

Intervention Type DRUG

oral capsule

Interventions

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CYC065

intravenous infusion

Intervention Type DRUG

Venetoclax

oral capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No