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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety

Outcome Time Frame:

over the course of study

Principal Investigator

Judy H Chiao, MD

Investigator Role:

Study Director

Investigator Affiliation:

Cyclacel Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

CYC116-06-01

NCT ID:

NCT00560716

Start Date:

June 2007

Completion Date:

November 2009

Related Keywords:

  • Solid Tumors
  • Neoplasms

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
South Texas Accelerated Research Therapeutics San Antonio, Texas  78229