Back to resultsAn Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
Primary Purpose
Prostate Cancer, Tumors
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
YM 155
Docetaxel
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, HRPC, Hormone Refractory Prostate Cancer, YM155, Treatment Outcome, Solid Tumors
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1. HRPC
2. Solid Tumors
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)
Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)
Secondary Outcome Measures
Assessment of safety and efficacy
Assessment of pharmacokinetics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00514267
Brief Title
An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the feasibility and safety of administering YM155 in combination with docetaxel
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Tumors
Keywords
Prostate Cancer, HRPC, Hormone Refractory Prostate Cancer, YM155, Treatment Outcome, Solid Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. HRPC
Arm Type
Experimental
Arm Title
2. Solid Tumors
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
YM 155
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)
Time Frame
2 cycles
Title
Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)
Time Frame
1 cycle
Secondary Outcome Measure Information:
Title
Assessment of safety and efficacy
Time Frame
10 cycles
Title
Assessment of pharmacokinetics
Time Frame
Part 1 only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
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