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NCT00560716 Clinical Trial

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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00560716
Other study ID # CYC116-06-01
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date June 2007
Est. completion date November 2009

Study information
Verified date December 2021
Source Cyclacel Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Other known NCT identifiers
  • NCT00530465

Recruitment information / eligibility
Status Terminated
Enrollment 25
Est. completion date November 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CYC116
Dose escalation of CYC116

Locations
Country Name City State
United States Roswell Park Cancer Institute Buffalo New York
United States South Texas Accelerated Research Therapeutics San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Cyclacel Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability Safety and tolerability; SAEs and AEs over the course of study
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