Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations
NCT ID: NCT05457257
Last Updated: 2025-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
43 participants
INTERVENTIONAL
2022-07-29
2025-07-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Olaparib
Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose of 300 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions
olaparib
300 mg (2x 150 mg tablets) twice daily
Enzalutamide OR abiraterone acetate
Enzalutamide:
Enzalutamide is available as capsules or tablets containing 40 mg of enzalutamide. Subjects will be administered study treatment orally at a dose of 160 mg once daily.
Abiraterone acetate with prednisone: Abiraterone acetate is available as tablets containing 250 mg of abiraterone acetate. Subjects will be administered study treatment orally at a dose of 1,000 mg once daily. Prednisone is 5mg twice daily. Prednisolone is permitted for use instead of prednisone if necessary.
enzalutamide
160 mg (4 x 40 mg capsules) once daily
abiraterone acetate
1,000 mg (4 x 250 mg tablets) once daily
Prednisone
5mg(5mg x 1 tablet) twice daily
Interventions
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olaparib
300 mg (2x 150 mg tablets) twice daily
enzalutamide
160 mg (4 x 40 mg capsules) once daily
abiraterone acetate
1,000 mg (4 x 250 mg tablets) once daily
Prednisone
5mg(5mg x 1 tablet) twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
3. Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .
4. Ongoing therapy with LHRH analog or bilateral orchiectomy.
5. Radiological progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
6. Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.
7. Normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
Exclusion Criteria
2. Subjects who had any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose \> 5 years prior to randomization.
3. History of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence.
4. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
18 Years
MALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Foundation Medicine
INDUSTRY
Myriad Genetics, Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Fangjian Zhou, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Research Site
Beijing, , China
Research Site
Bengbu, , China
Research Site
Changsha, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hefei, , China
Research Site
Jiaxing, , China
Research Site
Jinan, , China
Research Site
Jinan, , China
Research Site
Jining, , China
Research Site
Kunming, , China
Research Site
Lanzhou, , China
Research Site
Linyi, , China
Research Site
Nanchang, , China
Research Site
Nantong, , China
Research Site
Ningbo, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Suzhou, , China
Research Site
Taiyuan, , China
Research Site
Tianjin, , China
Research Site
Wanzhou, , China
Research Site
Wuhan, , China
Research Site
Wuxi, , China
Research Site
Wuxi, , China
Research Site
Xi'an, , China
Research Site
Zhengzhou, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D081LC00002
Identifier Type: -
Identifier Source: org_study_id