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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:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00514267
First received: August 7, 2007
Last updated: May 20, 2010
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors) [ Time Frame: 1 cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of safety and efficacy [ Time Frame: 10 cycles ] [ Designated as safety issue: No ]
  • Assessment of pharmacokinetics [ Time Frame: Part 1 only ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT00514267     History of Changes
Other Study ID Numbers: 155-CL-025
Study First Received: August 7, 2007
Last Updated: May 20, 2010
Health Authority: United States: Food and Drug Administration

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
Hormones
Prednisone
 Docetaxel
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013