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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.

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