NCT01023386CompletedPhase 1
A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. Infusion in Patients With Advanced Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion
Time Frame: Day -1 up to and including Day of discharge (Day 11)
Secondary Outcomes
- 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))
Investigators
Study Sites (1)
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