Cancer Clinical Trial
Official title:
A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
Verified date | January 2024 |
Source | Cyclacel Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 25, 2023 |
Est. primary completion date | October 4, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Cyclacel Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients who experience dose-limiting toxicities | cycle 1(each cycle is 21 -28 days) | ||
Secondary | Plasma concentrations | cycle 1(each cycle is 21 -28 days) | ||
Secondary | Half-life of CYC065 | cycle 1(each cycle is 21 -28 days) | ||
Secondary | changes in certain protein levels in peripheral white blood cells by western blots | cycle 1(each cycle is 21 -28 days) |
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