Phase 1 Study of Abiraterone Acetate in Castration-resistant Prostate Cancer
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess pharmacodynamics and safety of JNJ-212082 in order to
      select the recommended dose of JNJ-212082 for patients with castration resistant prostate
      cancer.
    

Detailed description: 
      This study is a multicenter (more than one site), open-label (both physician and patient know
      the name of the study drug), dose-escalation study in chemotherapy-naive patients with
      castration- resistant prostate cancer (CRPC) to evaluate the pharmacodynamics (the study of
      the action or effects of drugs on living organisms), safety, pharmacokinetics (how drugs are
      absorbed in the body, how they are distributed within the body and how they are removed from
      the body over time) and preliminary effectiveness of JNJ-212082. The dose of the study will
      be escalated from 250 mg (cohort 1), 500 mg (cohort 2), to 1000 mg (cohort 3). Six to twelve
      patients within each 250 mg, 500 mg or 1000 mg cohort will be orally administered drug once
      per day. Comprising 28 days for each 1 cycle, the administration will be continued up to
      discontinuation for any reasons such as progression of the disease or up to the transition to
      extension study (Protocol number: JNJ-212082-JPN-203) which will be separately planned. In
      addition, 5 mg of prednisolone will be orally administered twice per day since Day 8. On
      receiving notification of the confirmation of safety of 500 mg of the drug, patients of
      cohort 1 who are currently on continuous administration can receive increment 500 mg per day
      starting from the next cycle (If the dose escalation would not be appropriate due to safety
      reasons, the patients will continue the original dose). Furthermore, on receiving
      notification of the confirmation of safety of 1000 mg, patients of previous cohorts who are
      currently on continuous administration can receive increment 1000 mg per day as well from the
      next cycles (If the dose escalation would not be appropriate due to safety reasons, the
      patients will continue the original dose). JNJ-212082 will be orally administered once per
      day. Comprising 28 days for each 1 cycle, the administration will be continued up to
      discontinuation for any reasons such as progression of the disease or up to the transition to
      extension study. The drug will be administered at least 1 hour prior to meal or 2 hours after
      meal. The daily dose of the drug is defined as 250 mg, 500 mg or 1000 mg. In addition, 5 mg
      of prednisolone (marketed) will be orally administered twice per day since Day 8.
    

Intervention name(s): JNJ-212082
Intervention type(s): Drug
Intervention description(s): 250 mg, 500 mg or 1000 mg once daily up to discontinuation for any reasons such as progression of the disease or up to the transition to extension study.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Castration-resistant prostate cancer; Abiraterone acetate; JNJ-212082