A Phase I Pharmacologic Study of CYC116, an Oral Aurora K... | NCT00560716

Studies
A Phase I Pharmacologic Study of CYC116, an Oral Aurora Kinase Inhibitor, in Patients With Advanced Solid Tumors

NCT00560716

Sponsor

Cyclacel Pharmaceuticals, Inc.

Status

Terminated

Last Update Posted

Dec 22, 2021Actual

Enrollment

25Actual

Phase

Phase 1

Conditions

Solid Tumors

Interventions

CYC116

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jan 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Nov 16, 2007

First Submission Date that Met QC Criteria

Nov 16, 2007

First Posted Date

Nov 20, 2007Estimated

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

Dec 7, 2021

Last Update Posted Date

Dec 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a phase I study of an investigational cancer drug, CYC116, in patients with advanced solid tumors.

Detailed Description

Phase I study of an investigational cancer drug, CYC116, an Aurora kinase inhibitor, in patients with advanced solid tumors.

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CYC116	Experimental	CYC116 dose escalation first-in-human evaluation	Drug: CYC116

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CYC116	Drug	Dose escalation of CYC116	CYC116	Aurora kinase inhibitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability	Safety and tolerability; SAEs and AEs	over the course of study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Incurable advanced solid tumors that did not respond to conventional therapy or for which no effective therapy exists
Age >=18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy ≥ 3 months
Evaluable disease
Adequate bone marrow function
Adequate renal function
Adequate liver function
At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
Able to swallow capsules
At least 3 weeks from major surgery
Agree to practice effective contraception

Exclusion Criteria:

Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis
Currently receiving radiotherapy, biological therapy, or any other investigational agents
Uncontrolled intercurrent illness
Pregnant or lactating women
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
Judy H Chiao, MD	Cyclacel Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Roswell Park Cancer Institute		Buffalo	New York	14263	United States
South Texas Accelerated Research Therapeutics

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

Intervention Browse Module

MeSH Terms

ID	Term
C550465	4-methyl-5-(2-(4-morpholinophenylamino)pyrimidin-4-yl)thiazol-2-amine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided