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

• Status: Completed
• Trial end date: 2017-10-06
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GU Research Network, LLC
• Collaborator: Churchill Pharmaceutical LLC
• Treatments: Abiraterone Acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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