A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers

A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers

This is an open-label, single arm, dose escalation study in patients with advanced cancers.

This is an open-label, single arm, dose escalation study in patients with advanced cancers. Treatment will be administered on an outpatient basis.

Inclusion Criteria:

• Histologically or cytologically confirmed solid tumors or lymphomas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
• 18 years or older
• ECOG performance status 0-1
• Life expectancy ≥ 3 months
• Evaluable disease
• Adequate organ functions
• 4 weeks from prior chemotherapy ( 6 weeks for mitomycin C and nitrosourea) , immunotherapy, investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
• At least 4 weeks from major surgery
• Agree to practice effective contraception
• Agree to follow protocol required evaluations
• Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

• Previously untreated CNS metastasis or progressive 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