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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SoluMatrix™ Abiraterone Acetate
Methylprednisolone
Sponsored by
GU Research Network, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Castrate Resistant Prostate Cancer (CRPC), metastatic, castrate resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • GU Research Network/Wichita Urology Group
  • GU Research Network/Urology PC
  • GU Research Network/Urology Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SoluMatrix™ Abiraterone Acetate

Arm Description

SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid)

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety as determined by adverse events deemed related to experimental treatment.

Secondary Outcome Measures

Change in incidence of Treatment-Emergent Adverse Events in relation to Core Study
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.,

Full Information

First Posted
August 30, 2016
Last Updated
July 20, 2020
Sponsor
GU Research Network, LLC
Collaborators
Churchill Pharmaceutical LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02887976
Brief Title
Extension of SoluMatrix TM Abiraterone Acetate in Patients Who Completed Study Number CHL-AA-201
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 6, 2017 (Actual)
Study Completion Date
October 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GU Research Network, LLC
Collaborators
Churchill Pharmaceutical LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Castrate Resistant Prostate Cancer (CRPC), metastatic, castrate resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SoluMatrix™ Abiraterone Acetate
Arm Type
Experimental
Arm Description
SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid)
Intervention Type
Drug
Intervention Name(s)
SoluMatrix™ Abiraterone Acetate
Other Intervention Name(s)
Yonza
Intervention Description
SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) is an androgen synthesis inhibitor
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
medrol, solumedrol
Intervention Description
Methylprednisolone (4mg bid) to maintain physiologic levels of corticosteroids which are reduced by SoluMatrix Abiraterone Acetate
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
Safety as determined by adverse events deemed related to experimental treatment.
Time Frame
Month 9
Secondary Outcome Measure Information:
Title
Change in incidence of Treatment-Emergent Adverse Events in relation to Core Study
Description
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.,
Time Frame
Month 9

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent obtained prior to any study-related procedure being performed Previous, uninterrupted enrollment and treatment in trial number CHL-AA-201. Exclusion Criteria: Progressive disease as ascertained by the investigator using standard-of-care evaluations. CHL-AA-201 D84 blood counts of the following: Absolute neutrophil count > 1500/µL Platelets > 100,000/µL Hemoglobin > 9 g/dL CHL-AA-201 D84 chemistry values of the following: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x Upper Limit of Normal (ULN) Total bilirubin < 1.5 x ULN Creatinine< 1.5 x ULN Albumin > 3.0 g/dL Potassium > 3.5 mmol/L
Facility Information:
Facility Name
GU Research Network/Wichita Urology Group
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
GU Research Network/Urology PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
GU Research Network/Urology Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Peer reviewed Journal and/or professional meeting.

Learn more about this trial

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

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