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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-10-06

Brief Summary

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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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Detailed Description

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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..

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SoluMatrix™ Abiraterone Acetate

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

Group Type EXPERIMENTAL

SoluMatrix™ Abiraterone Acetate

Intervention Type DRUG

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

Methylprednisolone

Intervention Type DRUG

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

Interventions

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SoluMatrix™ Abiraterone Acetate

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

Intervention Type DRUG

Methylprednisolone

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

Intervention Type DRUG

Other Intervention Names

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Yonza medrol solumedrol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No