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

Sponsor
Cyclacel Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00560716
Collaborator
(none)
25
Enrollment
2
Locations
1
Arm
29
Duration (Months)
12.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
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 :
Jun 1, 2007
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: CYC116

CYC116 dose escalation first-in-human evaluation

Drug: CYC116
Dose escalation of CYC116
Other Names:
  • Aurora kinase inhibitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability [over the course of study]

      Safety and tolerability; SAEs and AEs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263
    2 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.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cyclacel Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT00560716
    Other Study ID Numbers:
    • CYC116-06-01
    • NCT00530465
    First Posted:
    Nov 20, 2007
    Last Update Posted:
    Dec 22, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Dec 22, 2021