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
1 other identifier
interventional
2
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 prostate-cancer
Started Sep 2016
Shorter than P25 for phase_3 prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2017
CompletedJuly 22, 2020
August 1, 2016
1.1 years
August 30, 2016
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety as determined by adverse events deemed related to experimental treatment.
Month 9
Secondary Outcomes (1)
Change in incidence of Treatment-Emergent Adverse Events in relation to Core Study
Month 9
Study Arms (1)
SoluMatrix™ Abiraterone Acetate
EXPERIMENTALSoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid)
Interventions
SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) is an androgen synthesis inhibitor
Methylprednisolone (4mg bid) to maintain physiologic levels of corticosteroids which are reduced by SoluMatrix Abiraterone Acetate
Eligibility Criteria
You may qualify if:
- Written informed consent obtained prior to any study-related procedure being performed
- Previous, uninterrupted enrollment and treatment in trial number CHL-AA-201.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GU Research Network, LLClead
- Churchill Pharmaceutical LLCcollaborator
Study Sites (3)
GU Research Network/Wichita Urology Group
Wichita, Kansas, 67226, United States
GU Research Network/Urology PC
Lincoln, Nebraska, 68516, United States
GU Research Network/Urology Cancer Center
Omaha, Nebraska, 68130, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2016
First Posted
September 2, 2016
Study Start
September 1, 2016
Primary Completion
October 6, 2017
Study Completion
October 6, 2017
Last Updated
July 22, 2020
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
Peer reviewed Journal and/or professional meeting.