A Placebo Controlled Phase III Double Blind Study of ITK-1 in Patients with Prostate Cancer - A Clinical Evaluation of ITK-1 in Castration-Resistant, Docetaxel Refractory Prostate Cancer Patients with HLA-A24 positive <Confirmatory Study>
Phase 3
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000011308
- Lead Sponsor
- BrightPath Biotherapeutics Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 333
Inclusion Criteria
Not provided
Exclusion Criteria
1.Received the Taxane antitumor agents except for Docetaxcel 2. Hypersensitivity to mineral oil or mannitol oleate 3. Severe complications 4. Active multiple cancers 5. Received ITK-1 in the past 6. Entry to the other clinical trial within 2 months prior to entry to this study 7. Difficult to participate in this trial because of psychiatric symptoms 8. The patient who is suspected to suffer from any improper disadvantages by not participating in this study 9. Any other cases who are judged as being ineligible for this study by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method 1.Survival rate at 12 months 2.Serum prostate specific antigen (PSA) level 3.Anti-peptide antibody titer 4.Cytotoxic T lymphocyte activity 5.Frequency of adverse reactions and adverse events