A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced... | NCT03884829

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

NCT03884829

Sponsor

Cyclacel Pharmaceuticals, Inc.

Status

Terminated

Last Update Posted

Sep 19, 2024Actual

Enrollment

7Actual

Phase

Phase 1

Conditions

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

Interventions

CYC140

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Switch to oral formulation of CYC140 (plogosertib)

Expanded Access Info

Start Date

Mar 25, 2019Actual

Primary Completion Date

Nov 29, 2021Actual

Completion Date

Oct 19, 2023Actual

First Submitted Date

Oct 28, 2018

First Submission Date that Met QC Criteria

Mar 19, 2019

First Posted Date

Mar 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2024

Last Update Posted Date

Sep 19, 2024Actual

Name	Class
M.D. Anderson Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CYC140 single agent	Experimental	CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle	Drug: CYC140

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CYC140	Drug	CYC140 single agent	CYC140 single agent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients who experience dose -limiting toxicity (DLT)		At end of cycle 1 (each cycle is 21 days)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic measurement - area under the curve (AUC)	plasma drug exposure area under the curve (AUC)	At the end of cycle 1 (each cycle is 21 days)

Other Outcomes

Measure	Description	Time Frame
Anti-tumor activity	complete remission, partial remission	First dose of CYC140 to 4 weeks after the last dose of CYC140

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gautam Borthakur, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center		Houston	Texas	77030	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D009190	Myelodysplastic Syndromes
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007938	Leukemia

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.