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

Cyclacel Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Solid Tumors

Treatments

Drug: CYC116

Study type

Interventional

Funder types

Industry

Identifiers

CYC116-06-01

Details and patient eligibility

About

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

Full description

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

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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