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

Primary Purpose

AML, Adult, Myelodysplastic Syndromes, ALL, Adult

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CYC140

About this trial

This is an interventional treatment trial for AML, Adult focused on measuring AML, ALL, CLL, CML, MDS, advanced leukemias, leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CYC140 single agent

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetic measurement - area under the curve (AUC)

plasma drug exposure area under the curve (AUC)

Full Information

NCT ID

NCT03884829

First Posted

October 28, 2018

Last Updated

April 22, 2022

Sponsor

Cyclacel Pharmaceuticals, Inc.

Collaborators

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03884829

Brief Title

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

Official Title

A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients With Advanced Leukemias or Myelodysplastic Syndromes

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 25, 2019 (Actual)

Primary Completion Date

April 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cyclacel Pharmaceuticals, Inc.

Collaborators

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

AML, ALL, CLL, CML, MDS, advanced leukemias, leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CYC140 single agent

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CYC140

Intervention Description

CYC140 single agent

Primary Outcome Measure Information:

Title

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

Time Frame

At end of cycle 1 (each cycle is 21 days)

Secondary Outcome Measure Information:

Title

Pharmacokinetic measurement - area under the curve (AUC)

Description

plasma drug exposure area under the curve (AUC)

Time Frame

At the end of cycle 1 (each cycle is 21 days)

Other Pre-specified Outcome Measures:

Title

Anti-tumor activity

Description

complete remission, partial remission

Time Frame

First dose of CYC140 to 4 weeks after the last dose of CYC140

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mark Kirschbaum, MD

Phone

6263163394

mkirschbaum@cyclacel.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gautam Borthakur, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hind Alazzawi

Phone

713-794-4823

halazzawi@mdanderson.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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