Optimizing Abiraterone Therapy | NCT02426333

Studies
Optimizing Abiraterone Therapy

NCT02426333

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Sep 13, 2019Actual

Enrollment

56Actual

Phase

Not provided

Conditions

Metastatic Castration Resistant Prostate Cancer

Interventions

Abiraterone Acetate

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Apr 24, 2019Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

Mar 27, 2015

First Submission Date that Met QC Criteria

Apr 23, 2015

First Posted Date

Apr 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2019

Last Update Posted Date

Sep 13, 2019Actual

Name	Class
Janssen-Cilag Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abiraterone Acetate		abiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study	Other: Abiraterone Acetate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Abiraterone Acetate	Other	Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)	Abiraterone Acetate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
abiraterone AUC		6 months

Secondary Outcomes

Measure	Description	Time Frame
biomarkers: relation between biomarkers and treatment response	relation between biomarkers and treatment response	6 months
biomarker reduction	To explore the if reduction in biomarkers is related to treatment response after three and six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
Age ≥18 years
Feasible to collect blood samples from
Life expectancy of > 6 months
Measurable disease
Able and willing to give written informed consent prior to screening and enrollment

Exclusion Criteria:

other anticancer therapies
potent CYP3A4 inducers
herbal medicine that could interfere with abiraterone exposure

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nielka van Erp, PharmD, PhD	Radboud University Medical Center	Principal Investigator
Jack Schalken, PhD	Radboud University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jeroen Bosch Ziekenhuis		's-Hertogenbosch			Netherlands
Canisius Wilhelmina Ziekenhuis

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069501	Abiraterone Acetate

Ancestor Terms

ID	Term
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided