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This is an open-label, single-arm, multi-center extension study to evaluate safety in patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid). Patients will have successfully completed an 84-day treatment with abiraterone acetate in a previous trial. Results from the final visit of the previous study will be used to determine patient's eligibility for this study. Patients in this study will be eligible to receive open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of serum testosterone and PSA levels will be monitored. Disease progression will be assessed by PCWG2 criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YONSA with Methylprednisolone | Experimental | Aberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abiraterone acetate with Methylprednisolone | Drug | YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events | Adverse events | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Disease Progression | Number of participants who had disease progression | one year |
| Testosterone Levels | Change in serum testosterone levels from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Nemeth, Ph.D. | Churchill Pharmaceuticals LLC | Study Director |
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We do not plan to make individual participant data available
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A total of 20 subjects were enrolled in the study. Of these, 9 subjects were previously treated with YONSA and 11 subjects were previously treated with Zytiga in CHL-AA-201. Twelve (60.0%) subjects completed the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Preceding Treatment - Yonsa | 84-days treatment: Yonsa 500 mg orally once daily with methylprednisolon |
| FG001 | Preceding Treatment - Zytiga | Yonsa 500 mg orally once daily with methylprednisolon |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preceding Treatment - Yonsa | 84-days treatment |
| BG001 | Preceding Treatment - Zytiga | 84 day treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Adverse Events | Adverse events | subjects who were enrolled and who received at least 1 dose of study drug of Yonsa | Posted | Number | Participants | one year |
|
|
One year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preceding Treatment - Yonsa | one year treatment | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Septic shock | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harin Mehta | Sun Pharma Global FZE | 97145520096, 912266455645 | clinicaltrials@sparcmail.com, harin.mehta@sparcmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2017 | May 2, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Baseline and 360 days |
| Prostate Specific Antigen Levels | Change in serum testosterone levels after one year of treatment against baseline | One year |
| Testosterone Complete Suppression | Proportion of subjects with complete suppression of testosterone levels | 360 days |
| Percentage of Subjects With Prostate Specific Antigen - 50 Response | A decrease of ≥50% reduction from baseline of the study CHL-AA-201 | 360 days |
| Withdrawal by Subject |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Proportion of Subjects With Disease Progression | Number of participants who had disease progression | Posted | Count of Participants | Participants | one year |
|
|
|
|
| Secondary | Testosterone Levels | Change in serum testosterone levels from baseline | Posted | Mean | Standard Deviation | ng/dL | Baseline and 360 days |
|
|
|
| Secondary | Prostate Specific Antigen Levels | Change in serum testosterone levels after one year of treatment against baseline | Posted | Mean | Standard Deviation | ng/dL | One year |
|
|
|
| Secondary | Testosterone Complete Suppression | Proportion of subjects with complete suppression of testosterone levels | Posted | Number | percentage of subjects | 360 days |
|
|
|
| Secondary | Percentage of Subjects With Prostate Specific Antigen - 50 Response | A decrease of ≥50% reduction from baseline of the study CHL-AA-201 | Posted | Number | percentage of number of subjects | 360 days |
|
|
|
| 9 |
| 3 |
| 9 |
| 8 |
| 9 |
| EG001 | Preceding Treatment - Zytiga | one year treatment | 0 | 11 | 1 | 11 | 9 | 11 |
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Abasia | General disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Right leg cellulitis | Infections and infestations | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| -Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abasia | General disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Face oedema | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Mass | General disorders | Systematic Assessment |
|
| Nodule | General disorders | Systematic Assessment |
|
| Non-cardiac chest pai | General disorders | Systematic Assessment |
|
| Peripheral swelling | General disorders | Systematic Assessment |
|
| Ulcer | General disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |