Solid Tumors
Conditions
Brief summary
This is a phase I study of an investigational cancer drug, CYC116, in patients with advanced solid tumors.
Detailed description
Phase I study of an investigational cancer drug, CYC116, an Aurora kinase inhibitor, in patients with advanced solid tumors.
Interventions
DRUGCYC116
Dose escalation of CYC116
Sponsors
Cyclacel Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | over the course of study | Safety and tolerability; SAEs and AEs |
Countries
United States
Outcome results
None listed