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

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02887976

Run by

GU Research Network, LLC

People needed

2

Starts

2016-09-01

Expected to finish

2017-10-06

Last updated by the study team

2020-07-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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