NCT02887976

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: GU Research Network, LLC · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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..

Conditions

• Prostate Cancer

Interventions

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

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-10-06
• Completion: 2017-10-06
• First posted: 2016-09-02
• Last updated: 2020-07-22

Locations

3 sites across 1 country: United States