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

This study has been terminated.
(Sponsor decision)
Information provided by:
Cyclacel Pharmaceuticals, Inc. Identifier:
First received: November 16, 2007
Last updated: October 21, 2009
Last verified: November 2007
This is a phase I study of an investigational cancer drug, CYC116, in patients with advanced solid tumors.

Condition Intervention Phase
Solid Tumors
Drug: CYC116
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Pharmacologic Study of CYC116, an Oral Aurora Kinase Inhibitor, in Patients With Advanced Solid Tumors

Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • safety [ Time Frame: over the course of study ]

Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: November 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CYC116
    Dose escalation of CYC116

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00560716

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Study Director: Judy H Chiao, MD Cyclacel Pharmaceuticals, Inc.
  More Information

Responsible Party: Judy H. Chiao, M.D., VP of Clinical Development and Regulatory Affairs, Cyclacel Identifier: NCT00560716     History of Changes
Obsolete Identifiers: NCT00530465
Other Study ID Numbers: CYC116-06-01
Study First Received: November 16, 2007
Last Updated: October 21, 2009 processed this record on May 22, 2017