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Completed

NCT Number: NCT00514267

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

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

Completed

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Tumors Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YM 155

Drug

IV

docetaxel

Drug

IV

Prednisone

Drug

Oral

Primary outcomes

  1. Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)

    Time frame: 2 cycles

  2. Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)

    Time frame: 1 cycle

Secondary outcomes

  1. Assessment of safety and efficacy

    Time frame: 10 cycles

  2. Assessment of pharmacokinetics

    Time frame: Part 1 only

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase I/II Multicenter, Open-Label Study of YM155 Plus Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 9, 2007
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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