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NCT Number: NCT02887976

Extension of SoluMatrix TM Abiraterone Acetate 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

GU Research Network/Wichita Urology Group, Wichita, Kansas, United States

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About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SoluMatrix™ Abiraterone Acetate

Drug

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

Other names: Yonza

methylprednisolone

Drug

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

Other names: medrol, solumedrol

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Time frame: Month 9

    Safety as determined by adverse events deemed related to experimental treatment.

Secondary outcomes

  1. 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.,

Sponsors and collaborators

Lead sponsor

GU Research Network, LLC

Other

Collaborators

  • Churchill Pharmaceutical LLC

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2016
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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