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

GU Research Network, LLC

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Methylprednisolone; Drug: SoluMatrix™ Abiraterone Acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02887976

GURN-AA-201-OLE

Details and patient eligibility

About

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.

Full 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..

Enrollment: 2 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

SoluMatrix™ Abiraterone Acetate

Experimental group

Description:

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

Treatment:

Drug: SoluMatrix™ Abiraterone Acetate

Drug: Methylprednisolone