Phase 1 Study of Abiraterone Acetate in Castration-resistant Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01186484
First received: August 19, 2010
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
Drug: JNJ-212082
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of JNJ-212082 (Abiraterone Acetate) in Patients With Castration-Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • The pharmacodynamics (serum concentrations of corticosterone, testosterone, DHEA-S, 11-deoxycorticosterone) [ Time Frame: At Days 1, 2, and 8 of Cycle 1 ] [ Designated as safety issue: No ]
  • The number of patients reporting adverse events as a measure of safety [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma concentrations of abiraterone acetate and abiraterone [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Rates of decrease of prostate specific antigen (PSA)>50% (criteria of PCWG2 - Prostate Cancer Clinical Trials Working Group) [ Time Frame: Maximum 52 weeks ] [ Designated as safety issue: No ]
  • Tumor regression in patients with measurable lesions (RECIST - Response evaluation criteria in solid tumors) [ Time Frame: Maximum 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: June 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
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
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.

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- resistant prostate cancer (CRPC) to evaluate the pharmacodynamics (the study of the action or effects of drugs on living organisms), safety, pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) and preliminary effectiveness of JNJ-212082. The dose of the study will be escalated from 250 mg (cohort 1), 500 mg (cohort 2), to 1000 mg (cohort 3). Six to twelve patients within each 250 mg, 500 mg or 1000 mg cohort will be orally administered drug once per day. Comprising 28 days for each 1 cycle, the administration will be continued up to discontinuation for any reasons such as progression of the disease or up to the transition to extension study (Protocol number: JNJ-212082-JPN-203) which will be separately planned. In addition, 5 mg of prednisolone will be orally administered twice per day since Day 8. On receiving notification of the confirmation of safety of 500 mg of the drug, patients of cohort 1 who are currently on continuous administration can receive increment 500 mg per day starting from the next cycle (If the dose escalation would not be appropriate due to safety reasons, the patients will continue the original dose). Furthermore, on receiving notification of the confirmation of safety of 1000 mg, patients of previous cohorts who are currently on continuous administration can receive increment 1000 mg per day as well from the next cycles (If the dose escalation would not be appropriate due to safety reasons, the patients will continue the original dose). JNJ-212082 will be orally administered once per day. Comprising 28 days for each 1 cycle, the administration will be continued up to discontinuation for any reasons such as progression of the disease or up to the transition to extension study. The drug will be administered at least 1 hour prior to meal or 2 hours after meal. The daily dose of the drug is defined as 250 mg, 500 mg or 1000 mg. In addition, 5 mg of prednisolone (marketed) will be orally administered twice per day since Day 8.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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, 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 Criteria:

  • 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
  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: NCT01186484

Locations
Japan
Fukuoka, Japan
Kashiwa, Japan
Koto-Ku, Japan
Sunto, Japan
Yokohama, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01186484     History of Changes
Other Study ID Numbers: CR017137, JNJ-212082-JPN-102
Study First Received: August 19, 2010
Last Updated: June 16, 2014
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center
United States: Food and Drug Administration

Keywords provided by Janssen Pharmaceutical K.K.:
Castration-resistant prostate cancer
Abiraterone acetate
JNJ-212082

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014