This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.
This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort, where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts, additional patients are included in Expansion Cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
oral
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kanto, Japan
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC
This measure will be assessed on the dose escalation cohorts.
Time frame: 3 months during the study
Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
This measure will be assessed on the dose expansion cohort
Time frame: Day 85 and end of long term dosing period
Prostate Specific Antigen (PSA) Response
Time frame: Day 85 and end of long term dosing period
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG
This measure will be assessed on the dose expansion cohort.
Time frame: 3 months during the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Kyusyu, Japan
Unnamed facility
Shikoku, Japan