An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155

NCT ID: NCT00818480

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2012-08-31

Brief Summary

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This protocol is open to subjects previously enrolled in and who had completed a Phase I or Phase II study administering YM155. Subjects who are receiving benefit from treatment with YM155 are eligible after completing the previous study.

Detailed Description

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The main objective of the study is to continue to evaluate the safety and efficacy of YM155.

Each subject will be treated at the dose he/she was receiving at the completion of his/her previous phase I or phase II YM155 study.

Conditions

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Prostate Cancer Melanoma Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. YM155

Group Type EXPERIMENTAL

YM155

Intervention Type DRUG

continuous infusion

Interventions

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YM155

continuous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completed a Phase I or II YM155 study with at least stable disease and continues to meet the criteria as stated in the previous YM155 study that allows for additional treatment with YM155
* Lack of progression based on the most recent radiological imaging, biochemical assessments and/or physical examination
* Negative pregnancy test result (females of child-bearing potential)

Exclusion Criteria

* More than 21 days (or 14 days depending on the study of origin) between the time the last infusion of YM155 was stopped in the previous study and the proposed start of the first infusion in this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sr. Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

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Institute for Drug Development

San Antonio, Texas, United States

Site Status

South Texas Accelerated

San Antonio, Texas, United States

Site Status

Huntsman Cancer Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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155-CL-101

Identifier Type: -

Identifier Source: org_study_id

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