Clinical trial · Interventional
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
NCT02887976CI-TRIAL-00046085completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylprednisolone | Drug | — | UNRESOLVED |
| SoluMatrix™ Abiraterone Acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SoluMatrix™ Abiraterone Acetate
- description
- SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid)
- interventionNames
- Drug: SoluMatrix™ Abiraterone Acetate
- Drug: Methylprednisolone
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
- timeFrame
- Month 9
- description
- Safety as determined by adverse events deemed related to experimental treatment.
Secondary outcomes (1)
- measure
- Change in incidence of Treatment-Emergent Adverse Events in relation to Core Study
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.