HLA-A24 positive patients with castration-resistant, docetaxel-refractory prostate cancer
Conditions
Interventions
investigational material(s)
Generic name etc : ITK-1
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :
Sponsors
-
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Written Informed Consent 2. HLA-A24 positive 3. Showing immune response to 2 or more out of 12 ITK-1 peptides 4. Diagnosed prostate cancer histopathologically 5. Met both criteria below for the treatment of prostate cancer. 1) Disease progression confirmed after the hormone therapy or the maximum androgen blockade (MAB) therapy 2) Disease progression confirmed after the treatment with docetaxel 6. Maintains castration status with 50 ng/dL (0.5 ng/mL) or less serum testosterone level 7. Serum PSA level >= 2 ng/mL 8. ECOG performance status of 0 or 1 9. Expected to survive more than 12 weeks 10. Adequate organ function 11. Agreed to perform contraception during the period from giving informed consent to 70 days after completion of administration of study drugs
Exclusion criteria
Exclusion criteria: 1.Prior use of taxane antineoplastic agents with the exception of docetaxel 2.History of hypersensitivity to mineral oil or mannitol oleate, or patients assessed by the investigator or sub-investigator as being ineligible (for participation in this study) because of severe hypersensitivity to other drugs 3.High-risk patients with severe complications other than prostate cancer. 4.Active multiple cancers, excluding intraepithelial carcinomas and mucosal carcinomas that are considered to have been cured by localized therapy 5.Prior use of one or more types of ITK-1 peptides 6.Entry into other clinical studies within 2 months prior to the start of this study, or current participation in other clinical studies 7.Difficulty to participate in this study due to complications of psychiatric symptoms 8.Patient suspected of experiencing improper disadvantages by not participating in this study 9.Any other patients who are assessed by the investigator or sub-investigator as being ineligible for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy confirmatory Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1.Survival at 12 months 2.Serum prostate-specific antigen (PSA) level 3.Anti-peptide antibody titer 4.Cytotoxic T-lymphocyte (CTL) activity | — |
Countries
Japan
Outcome results
None listed