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

CYC065-01

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

2015-09-28

2022-10-04

2023-08-25

Completed

Early phase I

60

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2024-01-25