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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00514267
First Posted: August 9, 2007
Last Update Posted: August 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
To determine the feasibility and safety of administering YM155 in combination with docetaxel

Condition Intervention Phase
Prostate Cancer Tumors Drug: YM 155 Drug: Docetaxel Drug: Prednisone Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC) [ Time Frame: 2 cycles ]
  • Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors) [ Time Frame: 1 cycle ]

Secondary Outcome Measures:
  • Assessment of safety and efficacy [ Time Frame: 10 cycles ]
  • Assessment of pharmacokinetics [ Time Frame: Part 1 only ]

Enrollment: 32
Study Start Date: May 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. HRPC Drug: YM 155
IV
Drug: Docetaxel
IV
Drug: Prednisone
Oral
Experimental: 2. Solid Tumors Drug: YM 155
IV
Drug: Docetaxel
IV

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514267


Locations
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Global Development
  More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00514267     History of Changes
Other Study ID Numbers: 155-CL-025
First Submitted: August 7, 2007
First Posted: August 9, 2007
Last Update Posted: August 13, 2015
Last Verified: July 2015

Keywords provided by Astellas Pharma Inc:
Prostate Cancer
HRPC
Hormone Refractory Prostate Cancer
YM155
Treatment Outcome
Solid Tumors

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisone
Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal