NCT00514267

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 13, 2015

Status Verified

July 1, 2015

Enrollment Period

2.8 years

First QC Date

August 7, 2007

Last Update Submit

July 23, 2015

Conditions

Prostate CancerTumors

Keywords

Prostate CancerHRPCHormone Refractory Prostate CancerYM155Treatment OutcomeSolid Tumors

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Assessment of safety and efficacy

    10 cycles

  • Assessment of pharmacokinetics

    Part 1 only

Study Arms (2)

1. HRPC

EXPERIMENTAL
Drug: YM 155Drug: DocetaxelDrug: Prednisone

2. Solid Tumors

EXPERIMENTAL
Drug: YM 155Drug: Docetaxel

Interventions

YM 155DRUG

IV

1. HRPC2. Solid Tumors
DocetaxelDRUG

IV

1. HRPC2. Solid Tumors
PrednisoneDRUG

Oral

1. HRPC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Radiation therapy within 4 weeks of the start of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Interventions

sepantroniumDocetaxelPrednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Central Contact

    Astellas Pharma Global Development

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 9, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 13, 2015

Record last verified: 2015-07

Locations

US(1)