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

NCT ID: NCT00560716

Last Updated: 2021-12-22

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-11-30

Brief Summary

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

Detailed Description

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

Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CYC116

CYC116 dose escalation first-in-human evaluation

Group Type EXPERIMENTAL

CYC116

Intervention Type DRUG

Dose escalation of CYC116

Interventions

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CYC116

Dose escalation of CYC116

Intervention Type DRUG

Other Intervention Names

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Aurora kinase inhibitor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cyclacel Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judy H Chiao, MD

Role: STUDY_DIRECTOR

Cyclacel Pharmaceuticals, Inc.

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CYC116-06-01

Identifier Type: -

Identifier Source: org_study_id

NCT00530465

Identifier Type: -

Identifier Source: nct_alias