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A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01834209
Expanded Access Status : No longer available
First Posted : April 17, 2013
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to collect additional safety data during treatment with abiraterone acetate plus prednisone or prednisolone among adult participants with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) who reside in areas in which abiraterone acetate is not yet available for this indication through local healthcare providers, and who are not eligible for enrollment into an available ongoing clinical study of abiraterone acetate.

Condition or disease Intervention/treatment
Prostate Neoplasms Drug: Abiraterone acetate Drug: Prednisone or prednisolone

Detailed Description:
This is an open-label (identity of assigned study drug will be known) early access protocol (EAP). Approximately 60 participants will be enrolled in this study. Participants will receive abiraterone acetate 1000 mg daily plus prednisone or prednisolone 5 mg daily. Treatment in 28-day cycles will continue until progression of clinical disease. Study drug will be provided until the company obtains market authorization and reimbursement in the participant countries for this indication.

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Study Type : Expanded Access
Official Title: Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer



Intervention Details:
  • Drug: Abiraterone acetate
    Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily for 28-day cycles
  • Drug: Prednisone or prednisolone
    5 mg tablet taken orally once daily

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Not have received cytotoxic chemotherapy regimens for metastatic castration-resistant prostate cancer
  • Have prostate cancer progression as assessed by the investigator with prostate-specific antigen progression according to Prostate Cancer Working Group 2 criteria
  • Have asymptomatic or mildly symptomatic prostate cancer
  • Have ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
  • Have Eastern Cooperative Oncology Group performance status of <=2
  • Laboratory values within protocol-defined parameters
  • Adequate liver function according to protocol-defined parameters
  • Be able to swallow the study drug whole as a tablet
  • Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

  • Eligible for another study of abiraterone acetate that is open to enrollment
  • Has received abiraterone acetate in the past or was enrolled in Studies COU-AA-301 or COU-AA-302
  • Has serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Has uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg); individuals with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
  • Has active or symptomatic viral hepatitis or chronic liver disease
  • Has a history of pituitary or adrenal dysfunction
  • Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease or left ventricular ejection fraction of <50% at baseline
  • Has atrial fibrillation or other cardiac arrhythmia
  • Has known brain metastasis
  • Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of castration-resistant prostate cancer (CRPC)
  • Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
  • Has an active infection or other medical condition that would make prednisone/prednisolone use contraindicated
  • Has had other anticancer therapy including cytotoxic, radionucleotide, and immunotherapy
  • Has had prior systemic treatment with an azole drug; diethylstilbestrol; PC-SPES; spironolactone; and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer, within 4 weeks of Cycle 1 Day 1
  • Is currently enrolled in an investigational drug or device study or has participated in such a study within 30 days of Day 1
  • Has a condition or situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant's participation in the study
  • Has partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834209


Locations
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Brazil
Belo Horizonte, Brazil
Brasilia, Brazil
Florianopolis, Brazil
Fortaleza, Brazil
Jau, Brazil
Porto Alegre, Brazil
Santo Andre, Brazil
Sao Paulo, Brazil
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01834209    
Other Study ID Numbers: CR100946
212082PCR3012 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Keywords provided by Janssen Research & Development, LLC:
Prostate neoplasms
Prostate cancer
Metastatic prostate cancer
Metatatic castration resistant prostate cancer
Abiraterone acetate
Prednisone
Prednisolone
Early access program
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
Prednisolone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors