Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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)
Sponsor:
Information provided by:
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00560716
First received: November 16, 2007
Last updated: October 21, 2009
Last verified: November 2007
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560716

Locations
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.
Investigators
Study Director: Judy H Chiao, MD Cyclacel Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Judy H. Chiao, M.D., VP of Clinical Development and Regulatory Affairs, Cyclacel
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014