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JNJ-212082

Phase 1

Prostatic Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Oct 23, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01186484Phase 1 Study of Abiraterone Acetate in Castration-resistant Prostate CancerPHASE1 COMPLETED 27Jun 1, 2010Oct 2, 2014Oct 23, 20175 Japan
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Study Endpoints
Primary Endpoints
The pharmacodynamics (serum concentrations of corticosterone, testosterone, DHEA-S, 11-deoxycorticosterone)
At Days 1, 2, and 8 of Cycle 1
The number of patients reporting adverse events as a measure of safety
4 weeks
Secondary Endpoints
Plasma concentrations of abiraterone acetate and abiraterone
4 weeks
Rates of decrease of prostate specific antigen (PSA)>50% (criteria of PCWG2 - Prostate Cancer Clinical Trials Working Group)
Maximum 52 weeks
Tumor regression in patients with measurable lesions (RECIST - Response evaluation criteria in solid tumors)
Maximum 52 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
001EXPERIMENTALJNJ-212082 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.
Interventions
NameTypeDescription
JNJ-212082DRUG250 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.
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Eligibility Criteria
Age Range20 Years — 99 Years
SexMALE
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * 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,...

Countries:Japan
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