Clinical trial · Interventional
A Clinical Pharmacological Study of YM155 After Intravenous Infusion in Patients With Advanced Cancer
A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. Infusion in Patients With Advanced Cancer
NCT01023386CI-TRIAL-00003364completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| YM155 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion
- timeFrame
- Day -1 up to and including Day of discharge (Day 11)
Secondary outcomes (2)
- measure
- To identify the metabolic profile of YM155
- timeFrame
- Day -1 up to and including Day of discharge (Day 11)
- measure
- To evaluate the safety and tolerability of YM155 through vital signs, laboratory analysis, adverse events, physical exams, ECOG performance status and echo-cardiography
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.