Phase I Study of Satraplatin Plus Prednisolone
Phase 1
- Conditions
- Metastatic Hormone Refractory Prostate Cancer
- Registration Number
- JPRN-jRCT2080220611
- Lead Sponsor
- Yakult Honsha Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
(1)Patients who are histologically or cytologically proven prostate cancer
(2)Patients who meet the diagnostic criteria of stage D2 metastatic prostate cancer
(3)Patients who are progressive after one docetaxel-based regimen for metastatic prostate cancer
(4)ECOG performance status (PS) :0-2
Exclusion Criteria
(1)Patients who have received more than one prior chemotherapy regimen for metastatic disease
(2)Patients who have received any chemotherapy within 21 days prior to registration
(3)Patients who have a serious concurrent uncontrolled medical disorder
(4)Patients with a known history of brain metastases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety
- Secondary Outcome Measures
Name Time Method pharmacokinetic profile and efficacy