Cancer
Conditions
Brief summary
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
Detailed description
This is an open-label, single arm, dose escalation study in patients with advanced cancers. Treatment will be administered on an outpatient basis.
Interventions
DRUGCYC065
Sponsors
Cyclacel Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who experience dose-limiting toxicities | cycle 1(each cycle is 21 -28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations | cycle 1(each cycle is 21 -28 days) |
| Half-life of CYC065 | cycle 1(each cycle is 21 -28 days) |
| changes in certain protein levels in peripheral white blood cells by western blots | cycle 1(each cycle is 21 -28 days) |
Countries
United States
Outcome results
None listed