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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01023386

Collaborator

(none)

Enrollment

Location

3.9

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: YM155	Phase 1

Study Design

Study Type:

Interventional

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 :

Nov 1, 2009

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Budapest		Hungary	1122

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair: Use Central Contact, Astellas Pharma Europe B.V.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01023386

Other Study ID Numbers:

155-CL-005
2008-002049-21

First Posted:

Dec 2, 2009

Last Update Posted:

Apr 13, 2010

Last Verified:

Apr 1, 2010

Keywords provided by , ,

Study Results

No Results Posted as of Apr 13, 2010