Trial document

PLEASE NOTE:
This study has been imported from ClinicalTrials.gov without additional data checks.

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DRKS-ID: DRKS00006473

Trial Description

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Title

A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this study is to collect follow-up safety data from participants in completed
abiraterone acetate studies for a maximum duration of 6 years.

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Brief Summary in Scientific Language

This is a nonrandomized (individuals will not be assigned by chance to study treatments),
open-label (individuals will know the identity of study treatments), long-term safety
follow-up study of abiraterone acetate in approximately 300 patients from other completed
abiraterone acetate clinical studies. Patients must have received at least 3 months of
treatment with abiraterone acetate and a low-dose corticosteroid and, based on investigator
assessment, may benefit from continued treatment. This study will consist of a screening
period followed by open-label treatment of continued abiraterone acetate access. The
patients will continue with the same abiraterone acetate and low-dose corticosteroid dosing
regimen they were receiving in the previous abiraterone acetate clinical study until the
investigator determines that the patient is no longer receiving benefit or the sponsor
terminates the study. Patients can be withdrawn from the study if an alternative access (eg,
patient-assistance program or commercial source of abiraterone acetate) is available and
feasible. Each cycle of treatment will be 28 days. Investigators will monitor and assess the
patients for response to treatment or progression according to routine practice or as
clinically indicated to determine whether continued treatment with abiraterone acetate is
warranted. No efficacy data are being collected. Safety will be monitored throughout the
study for a maximum duration of 6 years. End-of-study assessments will be performed at least
30 days after the last dose of abiraterone or upon early withdrawal.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

DRKS-ID: DRKS00006473
Date of Registration in DRKS: 2014/09/19
Date of Registration in Partner Registry or other Primary Registry: 2012/01/23
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]*
(leading) Ethics Committee No.: [---]*

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Secondary IDs

EudraCT-No. (for studies acc. to Drug Law): 2011-005243-28
Primary Registry-ID: NCT01517802 (ClinicalTrials.gov)
Sponsor-ID: CR100797 (Janssen Research & Development, LLC)
Other Secondary-ID: 212082PCR3010
Other Secondary-ID: 2011-005243-28

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Health Condition or Problem studied

Free text: Metastatic Castration-resistant Prostate Cancer
Free text: Metastatic Breast Cancer
ICD10: C61 - Malignant neoplasm of prostate
ICD10: C50 - Malignant neoplasm of breast

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Interventions/Observational Groups

Arm 1: Drug: Abiraterone acetate
Arm 2: Drug: Prednisone

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Treatment
Assignment: Single (group)
Phase: III
Off-label Drug use: [---]*

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Primary Outcome

- The number of participants affected by a serious adverse event; time frame: Up to 30 days after the last dose of study drug

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Secondary Outcome

[---]*

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Countries of Recruitment

US: United States
AU: Australia
BE: Belgium
DE: Germany
ES: Spain
UK: United Kingdom

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Locations of Recruitment

Hamburg

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Recruitment

Planned/Actual: [---]*
(Anticipated or Actual) Date of First Enrollment: 2012/03/31
Target Sample Size: 300
Monocenter/Multicenter trial: [---]*
National/International: [---]*

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: no minimum age
Maximum Age: no maximum age

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Additional Inclusion Criteria

- Currently participating in an abiraterone acetate clinical study considered complete
and had received at least 3 months of treatment with abiraterone acetate tablets.

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Exclusion Criteria

- Medical conditions that require hospitalization.

- Any condition or situation which, in the opinion of the investigator, may put the
patient at significant risk, may confound the study results, or may interfere
significantly with the patient's participation in the study.

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Addresses

Primary Sponsor
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- Janssen Research & Development, LLC
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Janssen Research & Development, LLC
- Janssen Research & Development, LLC Clinical Trial
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Public Queries
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- Janssen Research & Development, LLC
- Janssen Research & Development, LLC Clinical Trial
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Sources of Monetary or Material Support

[---]*
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up continuing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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Additional Trial Attributes

Urological disease prostate cancer
If other, please specify [---]*
Study recommendations
If other, please specify [---]*
German director of clinical investigation
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- [---]*
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Further contact
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- [---]*
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Function of contact [---]*
Non-interventional study [---]*
Stage
If other, please specify [---]*
Onset of therapy [---]*
If other, please specify [---]*

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .

Translation on version: 4
Last processed date by ClinicalTrials.gov: 2016/01/14

* This entry means the parameter is not applicable or has not been set.