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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Prostate Cancer, Tumors

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 cycles

Safety Issue:

Yes

Principal Investigator

Central Contact

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

155-CL-025

NCT ID:

NCT00514267

Start Date:

May 2007

Completion Date:

March 2010

Related Keywords:

  • Prostate Cancer
  • Tumors
  • Prostate Cancer
  • HRPC
  • Hormone Refractory Prostate Cancer
  • YM155
  • Treatment Outcome
  • Solid Tumors
  • Prostatic Neoplasms

Name

Location
Austin, Texas  78705