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

Stopped early · Phase 1

Conditions studied: Solid Tumors

In brief

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

Key facts

Study ID

NCT00560716

Run by

Cyclacel Pharmaceuticals, Inc.

People needed

25

Starts

2007-06-01

Expected to finish

2009-11-01

Last updated by the study team

2021-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.