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

Sponsor

GU Research Network, LLC (Other)

Overall Status

Completed

CT.gov ID

NCT02887976

Collaborator

Churchill Pharmaceutical LLC (Industry)

Enrollment

Locations

Arm

13.1

Duration (Months)

0.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: SoluMatrix™ Abiraterone Acetate Drug: Methylprednisolone	Phase 3

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..

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Oct 6, 2017

Actual Study Completion Date :

Oct 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SoluMatrix™ Abiraterone Acetate SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid)	Drug: SoluMatrix™ Abiraterone Acetate SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) is an androgen synthesis inhibitor Other Names: Yonza Drug: Methylprednisolone Methylprednisolone (4mg bid) to maintain physiologic levels of corticosteroids which are reduced by SoluMatrix Abiraterone Acetate Other Names: medrol solumedrol

Arm

Intervention/Treatment

Experimental: SoluMatrix™ Abiraterone Acetate

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

Drug: SoluMatrix™ Abiraterone Acetate

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

Other Names:

Yonza

Drug: Methylprednisolone

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

Other Names:

medrol

solumedrol

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.,

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent obtained prior to any study-related procedure being performed
Previous, uninterrupted enrollment and treatment in trial number CHL-AA-201.

Exclusion Criteria:

Progressive disease as ascertained by the investigator using standard-of-care evaluations.
CHL-AA-201 D84 blood counts of the following:
Absolute neutrophil count > 1500/µL
Platelets > 100,000/µL
Hemoglobin > 9 g/dL
CHL-AA-201 D84 chemistry values of the following:
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x Upper Limit of Normal (ULN)
Total bilirubin < 1.5 x ULN
Creatinine< 1.5 x ULN
Albumin > 3.0 g/dL
Potassium > 3.5 mmol/L

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GU Research Network/Wichita Urology Group	Wichita	Kansas	United States	67226
2	GU Research Network/Urology PC	Lincoln	Nebraska	United States	68516
3	GU Research Network/Urology Cancer Center	Omaha	Nebraska	United States	68130