An Open-Label Study of YM155 + Docetaxel in Subjects With... | NCT00514267

Studies
An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors

NCT00514267

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Aug 13, 2015Estimated

Enrollment

32Actual

Phase

Phase 1Phase 2

Conditions

Prostate Cancer
Tumors

Interventions

YM 155
Docetaxel
Prednisone

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

Jul 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

May 2007

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Aug 7, 2007

First Submission Date that Met QC Criteria

Aug 8, 2007

First Posted Date

Aug 9, 2007Estimated

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

Jul 23, 2015

Certification/Extension First Submitted that Passed QC Review

Jul 23, 2015

Certification/Extension First Posted Date

Aug 13, 2015Estimated

Last Update Submitted Date

Jul 23, 2015

Last Update Posted Date

Aug 13, 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

To determine the feasibility and safety of administering YM155 in combination with docetaxel

Detailed Description

This clinical trial is designed to include two parts:

Part 1: Assessment of feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (HRPC) [ ENROLLMENT COMPLETED ]

Part 2: Assessment of feasibility and safety of administering YM155 in combination with docetaxel in subjects with solid tumors (except HRPC).

This registration has been updated to reflect the design requirements of PART 2.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. HRPC	Experimental		Drug: YM 155 Drug: Docetaxel Drug: Prednisone
2. Solid Tumors	Experimental		Drug: YM 155 Drug: Docetaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YM 155	Drug	IV	1. HRPC 2. Solid Tumors
Docetaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)		2 cycles
Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)		1 cycle

Secondary Outcomes

Measure	Description	Time Frame
Assessment of safety and efficacy		10 cycles
Assessment of pharmacokinetics		Part 1 only

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Part 1:

Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.

Part 2:

Subjects with histologically and cytologically confirmed solid tumors with measurable disease (except HRPC).

Exclusion Criteria:

Radiation therapy within 4 weeks of the start of study drug

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
Central Contact	Astellas Pharma Global Development	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		San Antonio	Texas	78229	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D005832	Genital Diseases, Male

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C523798	sepantronium
D000077143	Docetaxel
D011241	Prednisone

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided