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Extension of SoluMatrix TM Abiraterone Acetate in Patients Who Completed Study Number CHL-AA-201

NCT02887976 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-07-22

No results posted yet for this study

Summary

An Open-label extension (OLE), expanded access study, to assess long-term safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in patients who completed study number CHL-AA-201.

Conditions

Interventions

DRUG

SoluMatrix™ Abiraterone Acetate

SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) is an androgen synthesis inhibitor

DRUG

Methylprednisolone

Methylprednisolone (4mg bid) to maintain physiologic levels of corticosteroids which are reduced by SoluMatrix Abiraterone Acetate

Sponsors & Collaborators

  • Churchill Pharmaceutical LLC

    collaborator INDUSTRY

  • GU Research Network, LLC

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-10-06
Completion
2017-10-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02887976 on ClinicalTrials.gov