NCT01186484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2014

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

4.3 years

First QC Date

August 19, 2010

Last Update Submit

October 19, 2017

Conditions

Prostatic Neoplasms

Keywords

Castration-resistant prostate cancerAbiraterone acetateJNJ-212082

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

001

EXPERIMENTAL

JNJ-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.

Drug: JNJ-212082

Interventions

JNJ-212082DRUG

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.

001

Eligibility Criteria

Age20 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Kashiwa, Japan

Location

Unknown Facility

Kōtoku, Japan

Location

Unknown Facility

Sunto, Japan

Location

Unknown Facility

Yokohama, Japan

Location

Related Publications (1)

  • Matsubara N, Uemura H, Fukui I, Niwakawa M, Yamaguchi A, Iizuka K, Akaza H. Phase-1 study of abiraterone acetate in chemotherapy-naive Japanese patients with castration-resistant prostate cancer. Cancer Sci. 2014 Oct;105(10):1313-20. doi: 10.1111/cas.12496. Epub 2014 Oct 4.

    PMID: 25117615DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Janssen Pharmaceutical K.K., Japan Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 23, 2010

Study Start

June 1, 2010

Primary Completion

October 2, 2014

Study Completion

October 2, 2014

Last Updated

October 23, 2017

Record last verified: 2017-10

Locations

JP(5)