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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887976
• Other study ID #: GURN-AA-201-OLE
• Status: Completed
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: October 6, 2017

Study information

• Verified date: August 2016
• Source: GU Research Network, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: October 6, 2017
• Est. primary completion date: October 6, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• SoluMatrix™ Abiraterone Acetate
SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) is an androgen synthesis inhibitor
• Methylprednisolone
Methylprednisolone (4mg bid) to maintain physiologic levels of corticosteroids which are reduced by SoluMatrix Abiraterone Acetate

Locations

Country	Name	City	State
United States	GU Research Network/Urology PC	Lincoln	Nebraska
United States	GU Research Network/Urology Cancer Center	Omaha	Nebraska
United States	GU Research Network/Wichita Urology Group	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
GU Research Network, LLC	Churchill Pharmaceutical LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Safety as determined by adverse events deemed related to experimental treatment.	Month 9
Secondary	Change in incidence of Treatment-Emergent Adverse Events in relation to Core Study	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.,	Month 9