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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02887976

Enrollment

Registered

2016-09-02

Start date

2016-09-30

Completion date

2017-10-06

Last updated

2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Castrate Resistant Prostate Cancer (CRPC), metastatic, castrate resistant

Brief summary

Detailed 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..

Interventions

DRUGSoluMatrix™ Abiraterone Acetate

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

DRUGMethylprednisolone

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Month 9	Safety as determined by adverse events deemed related to experimental treatment.

Secondary

Measure	Time frame	Description
Change in incidence of Treatment-Emergent Adverse Events in relation to Core Study	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.,

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026