NCT01692483

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy containing a taxane.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2.9 years

First QC Date

September 21, 2012

Last Update Submit

November 30, 2015

Conditions

Prostate Neoplasms

Keywords

Prostate neoplasmsProstate cancerCastration resistant prostate cancerHormone refractory prostate cancerAbiraterone acetateTaxane

Outcome Measures

Primary Outcomes (1)

  • Number of participants affected by an adverse event

    Up to 30 days after the last dose of study medication

Secondary Outcomes (1)

  • Number of patients with disease progression

    Baseline up to Week 40

Study Arms (1)

Abiraterone acetate plus prednisone

Drug: Abiraterone acetateDrug: Prednisone

Interventions

Abiraterone acetateDRUG

Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily

Abiraterone acetate plus prednisone
PrednisoneDRUG

Prednisone or prednisolone 5 mg tablet taken orally twice daily

Abiraterone acetate plus prednisone

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male Filipino patients with advanced metastatic castration resistant prostate cancer

You may qualify if:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Received at least 1 but not more than 2 cytotoxic chemotherapy regimens for metastatic castration resistant prostate cancer (CRPC) (at least 1 regimen must have contained a taxane such as docetaxel; if a chemotherapy regimen containing a taxane is used more than once, this will be considered as 1 regimen)
  • Agrees to protocol-defined use of effective contraception
  • Laboratory values within protocol -defined parameters

You may not qualify if:

  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Abnormal liver function
  • Uncontrolled hypertension (systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=95 mmHg)
  • Active or symptomatic viral hepatitis or chronic liver disease
  • History of pituitary or adrenal dysfunction
  • 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 (NYHA) Class III or IV heart disease or left ventricular ejection fraction of \<50% at baseline
  • Known brain metastasis
  • History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug
  • Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE (Version 4.0) Grade of \<=1
  • Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole, ketoconazole) within 4 weeks of Cycle 1, Day 1
  • Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
  • Participation in an investigational drug trial within 30 days prior to selection
  • Known hypersensitivity to abiraterone acetate, or to any of the components in the formulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone AcetatePrednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsPregnadienesPregnanes

Study Officials

  • is Janssen Pharmaceutica, Philippines Clinical Trial

    Janssen Pharmaceutica, Philippines

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

September 25, 2012

Study Start

July 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

December 2, 2015

Record last verified: 2015-11