An Extension Study Administering YM155 to Subjects Previo... | NCT00818480

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

NCT00818480

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Sep 4, 2015Estimated

Enrollment

10Actual

Phase

Phase 2

Conditions

Prostate Cancer
Melanoma
Non-Hodgkin's Lymphoma

Interventions

YM155

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Mar 2011Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jan 6, 2009

First Submission Date that Met QC Criteria

Jan 6, 2009

First Posted Date

Jan 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 20, 2015

Certification/Extension First Submitted that Passed QC Review

Aug 20, 2015

Certification/Extension First Posted Date

Sep 4, 2015Estimated

Last Update Submitted Date

Aug 20, 2015

Last Update Posted Date

Sep 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. YM155	Experimental		Drug: YM155

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YM155	Drug	continuous infusion	1. YM155

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess Response Rate		End of Study up to 77 months
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)		End of Study up to 77 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sr. Medical Director	Astellas Pharma Global Development	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Drug Development		San Antonio	Texas	78229	United States
South Texas Accelerated

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D008545	Melanoma
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C523798	sepantronium

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided