One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™

• Sponsor: Sun Pharmaceutical Industries Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02962284
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Actual Duration (Months): 19

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Prostate Cancer	Drug: abiraterone acetate with Methylprednisolone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With YONSA™ 500 mg (4 x 125 mg qd) With Methylprednisolone (4 mg Bid)
• Actual Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: YONSA with Methylprednisolone Aberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)	Drug: abiraterone acetate with Methylprednisolone; YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid); Other Names: YONSA

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Adverse Events [one year]

   Adverse events

Secondary Outcome Measures

1. Proportion of Subjects With Disease Progression [one year]

   Number of participants who had disease progression

2. Testosterone Levels [Baseline and 360 days]

   Change in serum testosterone levels from baseline

3. Prostate Specific Antigen Levels [One year]

   Change in serum testosterone levels after one year of treatment against baseline

4. Testosterone Complete Suppression [360 days]

   Proportion of subjects with complete suppression of testosterone levels

5. Percentage of Subjects With Prostate Specific Antigen - 50 Response [360 days]

   A decrease of ≥50% reduction from baseline of the study CHL-AA-201

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Successful completion of 84 days of treatment with YONSA in Churchill Pharmaceuticals clinical trial, CHL-AA-201

• Last dose of YONSA or Zytiga within 45 days prior to treatment in this study

• Written informed consent obtained prior to any study-related procedure being performed

• Has in the investigator's opinion, the potential to gain clinical benefit with YONSA treatment

• Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level <50 ng/dL at screening

• Life expectancy of at least 9 months at screening

• Subject is willing and able to comply with all protocol requirements assessments

• Agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

• Serious concurrent illness, including psychiatric illness, that would interfere with study participation

• Inability to swallow tablets whole

• Known hypersensitivity to YONSA, methylprednisolone, or any excipients in study medications

• Moderate to severe hepatic impairment (Child-Pugh Classes B and C)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sun Pharmaceutical Industries Limited

Investigators

• Study Director: Paul Nemeth, Ph.D., Churchill Pharmaceuticals LLC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 2, 2017

More Information

Publications

None provided.

• Responsible Party: Sun Pharmaceutical Industries Limited
• ClinicalTrials.gov Identifier: NCT02962284
• Other Study ID Numbers: CHL-AA-202
• First Posted: Nov 11, 2016
• Last Update Posted: Nov 19, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Abiraterone Acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Recruitment Details	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

Arm/Group Title	Preceding Treatment - Yonsa	Preceding Treatment - Zytiga
Arm/Group Description	84-days treatment: Yonsa 500 mg orally once daily with methylprednisolon	Yonsa 500 mg orally once daily with methylprednisolon
Period Title: Overall Study
STARTED	9	11
COMPLETED	4	8
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Preceding Treatment - Yonsa	Preceding Treatment - Zytiga	Total
Arm/Group Description	84-days treatment	84 day treatment	Total of all reporting groups
Overall Participants	9	11	20
Age, Customized (Count of Participants)
<75 years	4 44.4%	5 45.5%	9 45%
≥75 years	5 55.6%	6 54.5%	11 55%
Sex/Gender, Customized (Count of Participants)
Male	9 100%	11 100%	20 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 22.2%	0 0%	2 10%
Not Hispanic or Latino	7 77.8%	11 100%	18 90%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Adverse Events
Description	Adverse events
Time Frame	one year

Outcome Measure Data

Analysis Population Description

subjects who were enrolled and who received at least 1 dose of study drug of Yonsa

Arm/Group Title	Preceding Treatment - Yonsa	Preceding Treatment - Zytiga
Arm/Group Description	one year treatment	one year treatment
Measure Participants	9	11
Number [Participants]	8 88.9%	9 81.8%

2. Secondary Outcome

Title	Proportion of Subjects With Disease Progression
Description	Number of participants who had disease progression
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preceding Treatment - Yonsa	Preceding Treatment - Zytiga
Arm/Group Description	84-days treatment	84 day treatment
Measure Participants	9	11
Count of Participants [Participants]	1 11.1%	3 27.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preceding Treatment - Yonsa, Preceding Treatment - Zytiga
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.1
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Testosterone Levels
Description	Change in serum testosterone levels from baseline
Time Frame	Baseline and 360 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preceding Treatment - Yonsa	Preceding Treatment - Zytiga
Arm/Group Description	84-days treatment	84 day treatment
Measure Participants	3	6
Mean (Standard Deviation) [ng/dL]	-6.24 (2.02)	-5.87 (3.64)

4. Secondary Outcome

Title	Prostate Specific Antigen Levels
Description	Change in serum testosterone levels after one year of treatment against baseline
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preceding Treatment - Yonsa	Preceding Treatment - Zytiga
Arm/Group Description	84-days treatment	84 day treatment
Measure Participants	5	9
Mean (Standard Deviation) [ng/dL]	-60.12 (115.63)	-112.76 (239.85)

5. Secondary Outcome

Title	Testosterone Complete Suppression
Description	Proportion of subjects with complete suppression of testosterone levels
Time Frame	360 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preceding Treatment - Yonsa	Preceding Treatment - Zytiga
Arm/Group Description	one year treatment	one year treatment
Measure Participants	5	8
Number [percentage of subjects]	100	87.5

6. Secondary Outcome

Title	Percentage of Subjects With Prostate Specific Antigen - 50 Response
Description	A decrease of ≥50% reduction from baseline of the study CHL-AA-201
Time Frame	360 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Preceding Treatment - Yonsa	Preceding Treatment - Zytiga
Arm/Group Description	one year treatment	one year treatment
Measure Participants	5	9
Number [percentage of number of subjects]	60.0	55.6

Adverse Events

Time Frame	One year
Arm/Group Title	Preceding Treatment - Yonsa		Preceding Treatment - Zytiga
Arm/Group Description	one year treatment		one year treatment
All Cause Mortality
	Preceding Treatment - Yonsa		Preceding Treatment - Zytiga
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/9 (22.2%)		0/11 (0%)
Serious Adverse Events
	Preceding Treatment - Yonsa		Preceding Treatment - Zytiga
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/9 (33.3%)		1/11 (9.1%)
General disorders
Abasia	1/9 (11.1%)		0/11 (0%)
Asthenia	1/9 (11.1%)		0/11 (0%)
Non-cardiac chest pain	1/9 (11.1%)		0/11 (0%)
Infections and infestations
Septic shock	1/9 (11.1%)		0/11 (0%)
Right leg cellulitis	0/9 (0%)		1/11 (9.1%)
Injury, poisoning and procedural complications
Head injury	1/9 (11.1%)		0/11 (0%)
Metabolism and nutrition disorders
Dehydration	1/9 (11.1%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Preceding Treatment - Yonsa		Preceding Treatment - Zytiga
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/9 (88.9%)		9/11 (81.8%)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/9 (11.1%)		0/11 (0%)
Leukocytosis	0/9 (0%)		1/11 (9.1%)
Cardiac disorders
Supraventricular tachycardia	0/9 (0%)		1/11 (9.1%)
Tachycardia	0/9 (0%)		1/11 (9.1%)
Ear and labyrinth disorders
Vertigo	0/9 (0%)		1/11 (9.1%)
Gastrointestinal disorders
-Dry mouth	0/9 (0%)		1/11 (9.1%)
Gastrooesophageal reflux disease	0/9 (0%)		1/11 (9.1%)
Nausea	1/9 (11.1%)		0/11 (0%)
Vomiting	1/9 (11.1%)		0/11 (0%)
General disorders
Abasia	1/9 (11.1%)		0/11 (0%)
Asthenia	1/9 (11.1%)		0/11 (0%)
Face oedema	1/9 (11.1%)		0/11 (0%)
Fatigue	1/9 (11.1%)		1/11 (9.1%)
Mass	1/9 (11.1%)		0/11 (0%)
Nodule	1/9 (11.1%)		0/11 (0%)
Non-cardiac chest pai	1/9 (11.1%)		0/11 (0%)
Peripheral swelling	1/9 (11.1%)		1/11 (9.1%)
Ulcer	1/9 (11.1%)		0/11 (0%)
Infections and infestations
Bronchitis	0/9 (0%)		2/11 (18.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.