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

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ClinicalTrials.gov Identifier: NCT00560716
Recruitment Status : Terminated (Sponsor decision)
First Posted : November 20, 2007
Last Update Posted : October 22, 2009
Sponsor:
Information provided by:
Cyclacel Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: CYC116 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2007
Actual Primary Completion Date : January 2009
Estimated Study Completion Date : November 2009

Intervention Details:
    Drug: CYC116
    Dose escalation of CYC116


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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

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
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: October 22, 2009
Last Verified: November 2007