A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01685983
First received: September 12, 2012
Last updated: July 5, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.

Condition Intervention Phase
Prostate Cancer
Drug: Abiraterone acetate
Drug: Prednisolone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Percentage of Participants With Prostate-specific Antigen (PSA) Response [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
    The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the time interval from the date of the first dose to the date of death.

  • Time to PSA Progression [ Time Frame: up to 15 months ] [ Designated as safety issue: No ]
    Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.

  • Percentage of Participants With Objective Radiographic Response [ Time Frame: up to 15 months ] [ Designated as safety issue: No ]
    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 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.

  • Serum Testosterone [ Time Frame: Baseline up to 15 months ] [ Designated as safety issue: No ]
    Median baseline testosterone concentration was reported at baseline.

  • Dehydroepiandrosterone (DHEA) Sulfate [ Time Frame: Baseline up to 15 months ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to 15 months ] [ Designated as safety issue: No ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.


Enrollment: 82
Study Start Date: August 2011
Estimated Study Completion Date: September 2016
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abiraterone actetate and Prednisolone Drug: Abiraterone acetate
Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.
Other Name: JNJ-212082
Drug: Prednisolone
Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.

Detailed Description:
This is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mCRPC. The study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled into this study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study. Patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
  • Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria
  • Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel
  • Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
  • Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment
  • Eastern Cooperative Oncology Group Performance Status less than or equal to 2

Exclusion Criteria:

  • Active or uncontrolled autoimmune disease that may require corticosteroid therapy
  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Uncontrolled hypertension
  • Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
  • Has abnormal liver function tests
  • Surgery or local prostatic intervention within 30 days of the first dose
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685983

Locations
Korea, Republic of
Busan, Korea, Republic of
Cheongju-Si, Korea, Republic of
Seongnam-Si, Gyeonggi-Do, Korea, Republic of
Seoul, Korea, Republic of
Taiwan
Kaohsiung, Taiwan
Taichung, Taiwan
Taichung City, Taiwan
Taipei, Taiwan
Taoyuan County, Taiwan
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01685983     History of Changes
Other Study ID Numbers: CR100009  212082PCR2007 
Study First Received: September 12, 2012
Results First Received: March 2, 2016
Last Updated: July 5, 2016
Health Authority: Taiwan: Taiwan Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Prostate Cancer
Metastatic-castration resistant prostate cancer
Prostate specific antigen
Abiraterone acetate
JNJ-212082
Abiraterone
Prednisolone
Androgen Deprivation
Docetaxel-based chemotherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisolone
Methylprednisolone Hemisuccinate
Abiraterone Acetate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Androgens
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on July 26, 2016