A Clinical Pharmacological Study of YM155 After Intravenous Infusion in Patients With Advanced Cancer
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ClinicalTrials.gov Identifier: NCT01023386 |
Recruitment Status :
Completed
First Posted : December 2, 2009
Last Update Posted : April 13, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Drug: YM155 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. Infusion in Patients With Advanced Cancer |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |
- Drug: YM155
I.V.
- 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) ]
- To identify the metabolic profile of YM155 [ Time Frame: 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 [ Time Frame: 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) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023386
Hungary | |
Budapest, Hungary, 1122 |
Study Chair: | Use Central Contact | Astellas Pharma Europe B.V. |
Responsible Party: | Disclosure Office Europe, Astellas Pharma Europe BV |
ClinicalTrials.gov Identifier: | NCT01023386 |
Other Study ID Numbers: |
155-CL-005 2008-002049-21 ( Other Identifier: EudraCT ) |
First Posted: | December 2, 2009 Key Record Dates |
Last Update Posted: | April 13, 2010 |
Last Verified: | April 2010 |
YM155 Mass-balance Phase I Pharmacokinetics |