search
Back to results

A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer Who Have Received Docetaxel

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Abiraterone
Prednisolone
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Abiraterone Acetate, JNJ-212082

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • In-patients or out-patients with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Have surgically or medically castrated, with testosterone levels of less than 50 nanogram per deciliter
  • Have Prostate Specific Antigen (PSA) level of at least 5 nanogram per milliliter
  • Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG) eligibility criteria or objective progression by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease after androgen deprivation
  • Have been used at least 1 but not more than 2 cytotoxic chemotherapy regimens for Metastatic Castration-Resistant Prostate Cancer (mCRPC). At least 1 regimen must have contained docetaxel. If docetaxel-containing chemotherapy was used more than once, those of regimens containing docetaxel would be considered as 1 regimen in total

Exclusion Criteria:

  • Has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels or any systemic corticosteroid within 4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer
  • Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy (including provenge) within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1
  • Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day 1. In addition, any clinically relevant sequel from the surgery must have resolved prior to Cycle 1 Day 1
  • Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart Association (NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less than 50 percent within 6 months prior to Cycle 1 Day 1
  • Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160 millimeter of mercury or diastolic blood pressure greater than or equal to 95 millimeter of mercury)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abiraterone

Arm Description

Abiraterone 1000 milligram (mg) oral tablets will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Prostate Specific Antigen (PSA) Response at Week 12
The PSA response will be evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline up to 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.

Secondary Outcome Measures

Percentage of Participants With Radiographic Objective Response
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Duration of Prostate Specific Antigen (PSA) Response
Duration of a PSA response is the time taken to achieve a PSA response that is decrease in PSA from Baseline by greater than or equal to 50 percent.
Percentage of Participants Achieving Prostate Specific Antigen (PSA) Response
The PSA response is decrease in PSA from Baseline by greater than or equal to 50 percent.
Clinical Benefit
Clinical Benefit is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. The SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease since treatment started.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
The ECOG PS score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature, for example, light housework, office work.
Decline in Serum Prostate Specific Antigen (PSA)
Decrease in serum PSA according to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criterion, which is, 25 percent increase in PSA and an absolute increase in PSA level by 2 nanogram per milliliter or more, from Baseline which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.
Overall Survival
Overall survival is defined as the time interval from the date of first dose to date of death.
Prostate Specific Antigen Based Progression-Free Survival (PSA-PFS)
The PSA-PFS is defined as time to first PSA failure that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter or death as per Prostate-Specific Antigen Working Group (PSAWG) criterion.
Radiographic Progression-Free Survival (RAD-PFS)
The RAD-PFS is defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. RAD-PFS will be evaluated according to RECIST Version 1.0.
Percentage of Participants With Circulating Tumor Cell (CTC) Conversion
The CTC is the pharmacodynamic potential predictive biomarker for tumor sensitivity.

Full Information

First Posted
January 30, 2013
Last Updated
November 3, 2015
Sponsor
Janssen Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01795703
Brief Title
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer Who Have Received Docetaxel
Official Title
A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration-Resistant Prostate Cancer Patients Who Have Received Docetaxel-based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) who have received docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents).
Detailed Description
This is a multi-center (conducted in more than one center), open-label (all people know the identity of the intervention), single-arm study to investigate safety and efficacy of abiraterone. The study consists of 3 phases: Screening phase (consists of 14 days before study commences on Day -1); Treatment phase (consists of 28-daily dosing cycles wherein abiraterone 1000 milligram [mg] once daily and 5 mg prednisolone twice daily will be given until disease progression or unacceptable toxicity is observed); and Follow-up phase (up to 5 years or until survival after the first dose of study drug). Abiraterone will be administered orally daily as at least 1 hour before the meal or 2 hours after the meal. Dose reduction will be allowed at the Investigator's discretion but not lower than 500 mg per day. Participants will discontinue study treatment at disease progression unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from abiraterone. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 12 weeks of therapy. Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Abiraterone Acetate, JNJ-212082

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abiraterone
Arm Type
Experimental
Arm Description
Abiraterone 1000 milligram (mg) oral tablets will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Abiraterone
Other Intervention Name(s)
JNJ-212082
Intervention Description
Abiraterone will be administered orally as 1000 milligram (mg) per day for 28-daily dosing cycles which will be continued until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Prednisolone will be administered orally as 5 mg tablets twice daily for 28-daily dosing cycle which will be continued until disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Prostate Specific Antigen (PSA) Response at Week 12
Description
The PSA response will be evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline up to 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Radiographic Objective Response
Description
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Time Frame
Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years
Title
Duration of Prostate Specific Antigen (PSA) Response
Description
Duration of a PSA response is the time taken to achieve a PSA response that is decrease in PSA from Baseline by greater than or equal to 50 percent.
Time Frame
Baseline and Day 1 of each cycle up to 5 years
Title
Percentage of Participants Achieving Prostate Specific Antigen (PSA) Response
Description
The PSA response is decrease in PSA from Baseline by greater than or equal to 50 percent.
Time Frame
Baseline and Day 1 of each cycle up to 5 years
Title
Clinical Benefit
Description
Clinical Benefit is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. The SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease since treatment started.
Time Frame
Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle up to 5 years
Title
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Description
The ECOG PS score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature, for example, light housework, office work.
Time Frame
Baseline, Day 1, 8, 15 and 22 of Cycle 1 and 2, and thereafter Day 1 and 15 of all cycles up to 5 years
Title
Decline in Serum Prostate Specific Antigen (PSA)
Description
Decrease in serum PSA according to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criterion, which is, 25 percent increase in PSA and an absolute increase in PSA level by 2 nanogram per milliliter or more, from Baseline which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.
Time Frame
Baseline and Day 1 of each cycle up to 5 years
Title
Overall Survival
Description
Overall survival is defined as the time interval from the date of first dose to date of death.
Time Frame
Every 3 months until death or up to 5 years
Title
Prostate Specific Antigen Based Progression-Free Survival (PSA-PFS)
Description
The PSA-PFS is defined as time to first PSA failure that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter or death as per Prostate-Specific Antigen Working Group (PSAWG) criterion.
Time Frame
Baseline and Day 1 of each cycle until first documented disease progression or up to 5 years
Title
Radiographic Progression-Free Survival (RAD-PFS)
Description
The RAD-PFS is defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. RAD-PFS will be evaluated according to RECIST Version 1.0.
Time Frame
Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression, or up to 5 years
Title
Percentage of Participants With Circulating Tumor Cell (CTC) Conversion
Description
The CTC is the pharmacodynamic potential predictive biomarker for tumor sensitivity.
Time Frame
Day 1 of Cycle 2, 3, and 4

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In-patients or out-patients with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology Have surgically or medically castrated, with testosterone levels of less than 50 nanogram per deciliter Have Prostate Specific Antigen (PSA) level of at least 5 nanogram per milliliter Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG) eligibility criteria or objective progression by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease after androgen deprivation Have been used at least 1 but not more than 2 cytotoxic chemotherapy regimens for Metastatic Castration-Resistant Prostate Cancer (mCRPC). At least 1 regimen must have contained docetaxel. If docetaxel-containing chemotherapy was used more than once, those of regimens containing docetaxel would be considered as 1 regimen in total Exclusion Criteria: Has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels or any systemic corticosteroid within 4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy (including provenge) within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1 Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day 1. In addition, any clinically relevant sequel from the surgery must have resolved prior to Cycle 1 Day 1 Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart Association (NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less than 50 percent within 6 months prior to Cycle 1 Day 1 Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160 millimeter of mercury or diastolic blood pressure greater than or equal to 95 millimeter of mercury)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Asahi
Country
Japan
City
Fukuoka
Country
Japan
City
Kanazawa
Country
Japan
City
Kita-Gun
Country
Japan
City
Kuki
Country
Japan
City
Kurashiki
Country
Japan
City
Maebashi
Country
Japan
City
Matsuyama
Country
Japan
City
Mitaka
Country
Japan
City
Niigata
Country
Japan
City
Osaka-Sayama
Country
Japan
City
Osaka
Country
Japan
City
Sagamihara
Country
Japan
City
Sakura
Country
Japan
City
Sapporo
Country
Japan
City
Tokyo
Country
Japan
City
Yokohama
Country
Japan
City
Yokosuka
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25425730
Citation
Satoh T, Uemura H, Tanabe K, Nishiyama T, Terai A, Yokomizo A, Nakatani T, Imanaka K, Ozono S, Akaza H. A phase 2 study of abiraterone acetate in Japanese men with metastatic castration-resistant prostate cancer who had received docetaxel-based chemotherapy. Jpn J Clin Oncol. 2014 Dec;44(12):1206-15. doi: 10.1093/jjco/hyu148. Epub 2014 Oct 1.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=2413&filename=JNJ-212082-JPN-202-Synopsis.pdf
Description
A Phase 2 Study of JNJ-212082 (abiraterone acetate) in Metastatic Castration-Resistant Prostate Cancer Patients Who Have Received Docetaxel-based Chemotherapy

Learn more about this trial

A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer Who Have Received Docetaxel

We'll reach out to this number within 24 hrs