Trial Outcomes & Findings for One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™ (NCT NCT02962284)
NCT ID: NCT02962284
Last Updated: 2021-11-19
Results Overview
Adverse events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
one year
Results posted on
2021-11-19
Participant Flow
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
Participant milestones
| Measure |
Preceding Treatment - Yonsa
84-days treatment: Yonsa 500 mg orally once daily with methylprednisolon
|
Preceding Treatment - Zytiga
Yonsa 500 mg orally once daily with methylprednisolon
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Preceding Treatment - Yonsa
84-days treatment: Yonsa 500 mg orally once daily with methylprednisolon
|
Preceding Treatment - Zytiga
Yonsa 500 mg orally once daily with methylprednisolon
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Progressive disease
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™
Baseline characteristics by cohort
| Measure |
Preceding Treatment - Yonsa
n=9 Participants
84-days treatment
|
Preceding Treatment - Zytiga
n=11 Participants
84 day treatment
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<75 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
≥75 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: subjects who were enrolled and who received at least 1 dose of study drug of Yonsa
Adverse events
Outcome measures
| Measure |
Preceding Treatment - Yonsa
n=9 Participants
one year treatment
|
Preceding Treatment - Zytiga
n=11 Participants
one year treatment
|
|---|---|---|
|
Number of Subjects With Adverse Events
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: one yearNumber of participants who had disease progression
Outcome measures
| Measure |
Preceding Treatment - Yonsa
n=9 Participants
one year treatment
|
Preceding Treatment - Zytiga
n=11 Participants
one year treatment
|
|---|---|---|
|
Proportion of Subjects With Disease Progression
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 360 daysChange in serum testosterone levels from baseline
Outcome measures
| Measure |
Preceding Treatment - Yonsa
n=3 Participants
one year treatment
|
Preceding Treatment - Zytiga
n=6 Participants
one year treatment
|
|---|---|---|
|
Testosterone Levels
|
-6.24 ng/dL
Standard Deviation 2.02
|
-5.87 ng/dL
Standard Deviation 3.64
|
SECONDARY outcome
Timeframe: One yearChange in serum testosterone levels after one year of treatment against baseline
Outcome measures
| Measure |
Preceding Treatment - Yonsa
n=5 Participants
one year treatment
|
Preceding Treatment - Zytiga
n=9 Participants
one year treatment
|
|---|---|---|
|
Prostate Specific Antigen Levels
|
-60.12 ng/dL
Standard Deviation 115.63
|
-112.76 ng/dL
Standard Deviation 239.85
|
SECONDARY outcome
Timeframe: 360 daysProportion of subjects with complete suppression of testosterone levels
Outcome measures
| Measure |
Preceding Treatment - Yonsa
n=5 Participants
one year treatment
|
Preceding Treatment - Zytiga
n=8 Participants
one year treatment
|
|---|---|---|
|
Testosterone Complete Suppression
|
100 percentage of subjects
|
87.5 percentage of subjects
|
SECONDARY outcome
Timeframe: 360 daysA decrease of ≥50% reduction from baseline of the study CHL-AA-201
Outcome measures
| Measure |
Preceding Treatment - Yonsa
n=5 Participants
one year treatment
|
Preceding Treatment - Zytiga
n=9 Participants
one year treatment
|
|---|---|---|
|
Percentage of Subjects With Prostate Specific Antigen - 50 Response
|
60.0 percentage of number of subjects
|
55.6 percentage of number of subjects
|
Adverse Events
Preceding Treatment - Yonsa
Serious events: 3 serious events
Other events: 8 other events
Deaths: 2 deaths
Preceding Treatment - Zytiga
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preceding Treatment - Yonsa
n=9 participants at risk
one year treatment
|
Preceding Treatment - Zytiga
n=11 participants at risk
one year treatment
|
|---|---|---|
|
Infections and infestations
Septic shock
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
Injury, poisoning and procedural complications
Head injury
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
General disorders
Abasia
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
General disorders
Asthenia
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
Infections and infestations
Right leg cellulitis
|
0.00%
0/9 • One year
|
9.1%
1/11 • One year
|
Other adverse events
| Measure |
Preceding Treatment - Yonsa
n=9 participants at risk
one year treatment
|
Preceding Treatment - Zytiga
n=11 participants at risk
one year treatment
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/9 • One year
|
9.1%
1/11 • One year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/9 • One year
|
9.1%
1/11 • One year
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • One year
|
9.1%
1/11 • One year
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • One year
|
9.1%
1/11 • One year
|
|
Gastrointestinal disorders
-Dry mouth
|
0.00%
0/9 • One year
|
9.1%
1/11 • One year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • One year
|
9.1%
1/11 • One year
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
General disorders
Abasia
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
General disorders
Asthenia
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
General disorders
Face oedema
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
General disorders
Fatigue
|
11.1%
1/9 • One year
|
9.1%
1/11 • One year
|
|
General disorders
Mass
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
General disorders
Nodule
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
General disorders
Non-cardiac chest pai
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
General disorders
Peripheral swelling
|
11.1%
1/9 • One year
|
9.1%
1/11 • One year
|
|
General disorders
Ulcer
|
11.1%
1/9 • One year
|
0.00%
0/11 • One year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • One year
|
18.2%
2/11 • One year
|
Additional Information
Harin Mehta
Sun Pharma Global FZE
Phone: 97145520096, 912266455645
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER