Status:
COMPLETED
Phase 1 Study of Abiraterone Acetate in Castration-resistant Prostate Cancer
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
20-99 years
Phase:
PHASE1
Brief 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- resista...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the prostate, but not with neuroendocrine differentiation or of small cell histology
- No Prior cytotoxic chemotherapy (including estramustine) for the treatment of prostate cancer
- Surgically or medically castrated, with testosterone levels of \< 0.5 ng/mL
- PSA level of at least 2 ng/ml at Screening
- PSA progression according to PCWG2 eligibility criteria or objective progression by RECIST criteria for patients with measurable disease after androgen deprivation
Exclusion
- Surgery or local prostatic intervention within 4 weeks of the first dose. In addition, any clinically relevant sequelae from the surgery have not resolved prior to initial treatment
- Radiotherapy, or immunotherapy within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks of administration prior to initial treatment
- Known brain metastasis
- Uncontrolled hypertension (systolic BP greater than 160 mmHg or diastolic BP greater than 95 mmHg)
- Active or symptomatic viral hepatitis or chronic liver disease
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01186484
Start Date
June 1 2010
End Date
October 2 2014
Last Update
October 23 2017
Active Locations (5)
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1
Fukuoka, Japan
2
Kashiwa, Japan
3
Kōtoku, Japan
4
Sunto, Japan