An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
Phase 1
Completed
- Conditions
- Prostate CancerTumors
- Interventions
- Registration Number
- NCT00514267
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1. HRPC YM 155 - 2. Solid Tumors YM 155 - 1. HRPC Docetaxel - 1. HRPC Prednisone - 2. Solid Tumors Docetaxel -
- Primary Outcome Measures
Name Time Method Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors) 1 cycle Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC) 2 cycles
- Secondary Outcome Measures
Name Time Method Assessment of pharmacokinetics Part 1 only Assessment of safety and efficacy 10 cycles