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

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 Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: SoluMatrix™ Abiraterone Acetate; Drug: Methylprednisolone

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Wichita, Kansas, United States, 67226
      • GU Research Network/Wichita Urology Group
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • GU Research Network/Urology PC
    • Omaha, Nebraska, United States, 68130
      • GU Research Network/Urology Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: solumedrol; medrol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GU Research Network, LLC
• Collaborators: Churchill Pharmaceutical LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): October 6, 2017
• Study Completion (Actual): October 6, 2017

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 2, 2016

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Prostate Cancer; metastatic; castrate resistant; Castrate Resistant Prostate Cancer (CRPC)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Abiraterone Acetate
• Other Study ID Numbers: GURN-AA-201-OLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Peer reviewed Journal and/or professional meeting.