Metastatic Prostate CancerPhase 2NCT02962284
One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™
A Phase 2 study testing abiraterone acetate with Methylprednisolone in people with Metastatic Prostate Cancer, run by Sun Pharmaceutical Industries Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- abiraterone acetate with Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
About this study
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)
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.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- abiraterone acetate with Methylprednisolone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abiraterone acetate with MethylprednisoloneDrug
Also called YONSA
YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)
| Study group | Role | What they receive |
|---|---|---|
| YONSA with Methylprednisolone | Experimental | Aberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid) Receives: Drug: abiraterone acetate with Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events
Adverse events
Measured: one year
Secondary outcomes (5)
Proportion of Subjects With Disease Progression
Number of participants who had disease progression
Measured: one year
Testosterone Levels
Change in serum testosterone levels from baseline
Measured: Baseline and 360 days
Prostate Specific Antigen Levels
Change in serum testosterone levels after one year of treatment against baseline
Measured: One year
Testosterone Complete Suppression
Proportion of subjects with complete suppression of testosterone levels
Measured: 360 days
Percentage of Subjects With Prostate Specific Antigen - 50 Response
A decrease of ≥50% reduction from baseline of the study CHL-AA-201
Measured: 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Nemeth, Ph.D., Study director, Churchill Pharmaceuticals LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962284
- Sponsor's protocol ID
- CHL-AA-202
- Status last verified
- Nov 2021
- First submitted
- 31 Oct 2016
- Last updated
- 19 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: We do not plan to make individual participant data available
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02962284
- Acronym / sponsor ID
- CHL-AA-202
- Conditions
- Metastatic Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Posted 22 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YONSA with Methylprednisolone | Experimental | Drug: abiraterone acetate with MethylprednisoloneAberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abiraterone acetate with MethylprednisoloneAlso: YONSAYONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid) | Drug | YONSA with Methylprednisolone |
Primary outcome
Number of Subjects With Adverse Events
Time frame: one year
Adverse events
5 secondary outcomes
Proportion of Subjects With Disease Progression
Time frame: one year
Testosterone Levels
Time frame: Baseline and 360 days
Prostate Specific Antigen Levels
Time frame: One year
Testosterone Complete Suppression
Time frame: 360 days
Percentage of Subjects With Prostate Specific Antigen - 50 Response
Time frame: 360 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data available
Related trials for Metastatic Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Nemeth, Ph.D. study director
Churchill Pharmaceuticals LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing abiraterone acetate with Methylprednisolone in people with Metastatic Prostate Cancer, run by Sun Pharmaceutical Industries Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Adverse Events (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.