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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00560716
Recruitment Status : Terminated (Sponsor decision)
First Posted : November 20, 2007
Last Update Posted : December 22, 2021
Sponsor:
Information provided by (Responsible Party):
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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
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
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: CYC116
CYC116 dose escalation first-in-human evaluation
Drug: CYC116
Dose escalation of CYC116
Other Name: Aurora kinase inhibitor




Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: over the course of study ]
    Safety and tolerability; SAEs and AEs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Study Director: Judy H Chiao, MD Cyclacel Pharmaceuticals, Inc.
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Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00560716    
Obsolete Identifiers: NCT00530465
Other Study ID Numbers: CYC116-06-01
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms