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

Last updated: July 20, 2020
Sponsor: GU Research Network, LLC
Overall Status: Completed

Phase

3

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

N/A

Clinical Study ID

NCT02887976
GURN-AA-201-OLE
  • Ages > 18
  • Male

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

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

  3. Absolute neutrophil count > 1500/µL

  4. Platelets > 100,000/µL

  5. Hemoglobin > 9 g/dL

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

  7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x UpperLimit of Normal (ULN)

  8. Total bilirubin < 1.5 x ULN

  9. Creatinine< 1.5 x ULN

  10. Albumin > 3.0 g/dL

  11. Potassium > 3.5 mmol/L

Study Design

Total Participants: 2
Study Start date:
September 01, 2016
Estimated Completion Date:
October 06, 2017

Study 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..

Connect with a study center

  • GU Research Network/Wichita Urology Group

    Wichita, Kansas 67226
    United States

    Site Not Available

  • GU Research Network/Urology PC

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • GU Research Network/Urology Cancer Center

    Omaha, Nebraska 68130
    United States

    Site Not Available

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