A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias 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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2023-10-19

Brief Summary

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A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes

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Detailed Description

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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.

Conditions

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AML, Adult Myelodysplastic Syndromes ALL, Adult CML, Refractory CLL, Refractory

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CYC140 single agent

CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle

Group Type EXPERIMENTAL

CYC140

Intervention Type DRUG

CYC140 single agent

Interventions

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CYC140

CYC140 single agent

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No