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

July 20, 2020 updated by: GU Research Network, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. An exploratory endpoint of Improved safety from switching from Zytiga (aberaterone Acetate 1000mg(4 x 250 mg qd) to SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) will also be ascertained..

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Wichita, Kansas, United States, 67226
        • GU Research Network/Wichita Urology Group
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • GU Research Network/Urology PC
      • Omaha, Nebraska, United States, 68130
        • GU Research Network/Urology Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Written informed consent obtained prior to any study-related procedure being performed
  2. Previous, uninterrupted enrollment and treatment in trial number CHL-AA-201.

Exclusion Criteria:

  1. Progressive disease as ascertained by the investigator using standard-of-care evaluations.

  2. CHL-AA-201 D84 blood counts of the following:

    1. Absolute neutrophil count > 1500/µL
    2. Platelets > 100,000/µL
    3. Hemoglobin > 9 g/dL

  3. CHL-AA-201 D84 chemistry values of the following:

    1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x Upper Limit of Normal (ULN)
    2. Total bilirubin < 1.5 x ULN
    3. Creatinine< 1.5 x ULN
    4. Albumin > 3.0 g/dL
    5. Potassium > 3.5 mmol/L

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SoluMatrix™ Abiraterone Acetate
SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid)
Drug: SoluMatrix™ Abiraterone Acetate
SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) is an androgen synthesis inhibitor
Other Names:
  • Yonza
Drug: Methylprednisolone
Methylprednisolone (4mg bid) to maintain physiologic levels of corticosteroids which are reduced by SoluMatrix Abiraterone Acetate
Other Names:
  • solumedrol
  • medrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: Month 9
Safety as determined by adverse events deemed related to experimental treatment.
Month 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in incidence of Treatment-Emergent Adverse Events in relation to Core Study
Time Frame: Month 9
Explore if a reduction in adverse events occurs in subjects completing core study originally assigned to Zytiga Abiraterone Acetate plus prednison and switched to SoluMatrix Abiraterone Acetate plus methylprednisolone.,
Month 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GU Research Network, LLC

Collaborators

Churchill Pharmaceutical LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

October 6, 2017

Study Completion (Actual)

October 6, 2017

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GURN-AA-201-OLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Peer reviewed Journal and/or professional meeting.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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