A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients with Advanced Cancers
Trial Description
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
Eligibility Requirements
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