A Clinical Pharmacological Study of YM155 After Intravenous Infusion in Patients With Advanced Cancer

Cancer Clinical Trial

Official title:

A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. Infusion in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023386
• Other study ID #: 155-CL-005
• Secondary ID: 2008-002049-21
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2009
• Last updated: April 12, 2010
• Start date: November 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• YM155
I.V.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	To identify the metabolic profile of YM155		Day -1 up to and including Day of discharge (Day 11)	No
Secondary	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)	No