Cancer
Conditions
Keywords
YM155, Mass-balance, Phase I, Pharmacokinetics
Brief summary
This study investigates the pharmacokinetics of YM155, identifies the metabolic profile of YM155 and evaluates the safety and tolerability of YM155 after a 3-hour infusion in patients with advanced cancer
Interventions
DRUGYM155
I.V.
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors or non-Hodgkin's lymphomas for which YM155 has the potential, based on preclinical and/or clinical data, to show efficacy, namely: * castrate resistant prostate cancer * non-small cell lung cancer * metastatic melanoma * muscle invasive bladder cancer * follicular lymphoma * diffuse large B-cell lymphoma * Life expectancy ≥ 3 months; and Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at baseline
Exclusion criteria
* Radiotherapy, major surgery, hormonal therapy, and chemotherapy within 4 weeks prior to the first dose of study medication and 6 weeks in the case of mitomycin-C or nitrosourea * Previous therapy with YM155 * Patients with renal, hepatic or colorectal cancers * Inadequate bone marrow, renal and/or hepatic function * History of being treated for other malignancy within 5 years except for treated basal or squamous cell carcinoma of the skin * Participation in any clinical study within 4 weeks prior to start of the first dose of study medication * Known brain or leptomeningeal metastases * Active uncontrolled systemic infection at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion | Day -1 up to and including Day of discharge (Day 11) |
Secondary
| Measure | Time frame |
|---|---|
| To identify the metabolic profile of YM155 | Day -1 up to and including Day of discharge (Day 11) |
| To evaluate the safety and tolerability of YM155 through vital signs, laboratory analysis, adverse events, physical exams, ECOG performance status and echo-cardiography | Screening (Day -21 to -2), Day -1 up to and including Day of discharge (Day 11) and end of study visit (7-14 weeks after discharge) |
Countries
Hungary
Outcome results
None listed