Metastatic Castration-resistant Prostate CancerPhase 2NCT05327621
Pamiparib in mCRPC With HRD or BRCA1/2 Mutation
A Phase 2 study testing Pamiparib in people with Metastatic Castration-resistant Prostate Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy of a PARP inhibitor, Pamiparib, in metastatic castration-resistant prostate cancer patients with homologous recombination deficiency or BRCA 1 or 2 somatic/germline mutation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Pamiparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 20 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- ≥18 years old, male
- Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma without neuroendocrine differentiation of the prostate. Mixed histology is accepted, except for small cell carcinoma.
- Have a deleterious mutation in BRCA1/2 , or HRD score ≥ 9.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- BPI<4
- Metastatic Castration-resistant Prostate Cancer (mCRPC): Presence of measurable target lesion according to RECIST criteria v1.1
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- Male subject has been surgically or medically sterilized and has serum testosterone level ≤1.73nmol/L.
- Unsterilized male subject uses an acceptable method of contraception (defined as a barrier method with spermicide) to prevent pregnancy during the duration of the study and for 6 months after the last dose of Pamiparib.
- Experienced disease progression after having received at least 1 prior next-generation androgen receptor-targeted therapies, for metastatic castration-resistant disease.
- Capable of swallowing the whole capsule.
- Subjects must have normal organ and bone marrow function at baseline, as defined below:
- Hemoglobin ≥ 9.0 g/dL at least 28 days after transfusion . Absolute neutrophil count ≥ 1.5 × 10^9/L. Platelet count ≥ 100 × 10^9/L. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) specified. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase) ≤ 3 × the specified ULN, unless liver metastases are present, in which case it must be ≤ 5 × ULN.
- Agree to sign informed consent form
- Agree not to participate in other interventional trials during this trial.
Who cannot join
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Acute toxicity (CTCAE > grade 2) due to prior cancer therapy.
- Received chemotherapy, endocrine therapy, biotherapy, radionuclide therapy, immunotherapy, experimental drugs, proprietary anticancer drugs or Chinese herbal medicines within 5 (if known) half-lives or 14 days(if unknown) prior to the first day of taking Pamiparib; For bisphosphonates or approved bone targeting therapy, Pamiparib must be administered at a steady dose for ≥28 days prior to the first day of taking Pamiparib.
- Received radiation therapy within 21 days.
- Prior treatment with any PARP inhibitor. Prior chemotherapy with mitoxantrone or platinum-based chemotherapy or cyclophosphamide. Prior treatment with sipuleucel-T or immune check point inhibitors are allowed.
- Subjects with major surgery within 2 weeks before starting study treatment. Subjects expected to receive major surgery during the trial.
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- Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
- Symptomatic and/or untreated central nervous system metastases
- Immunocompromised subjects, such as those with positive human immunodeficiency virus (HIV) serology.
- Subjects with known active hepatitis (e.g. hepatitis B or C).
- The subject has a serious cardiovascular disease. ( For example, but not limited to: uncontrolled arrhythmia, myocardial infarction)
- Concomitant use of strong CYP3A inducers or moderate CYP3A inducers . If half-lives is known, a 5 half-lives washout period is required before the start of Pamiparib therapy and a 2-week washout period is required when the half-lives is unknown.
- History of intolerance to Pamiparib capsule excipients
- Excluded by investigators
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fangjian Zhou, M.D., 020-87343656, zhoufj@sysucc.org.cn
Yonghong Li, M.D., 020-87343656, liyongh@sysucc.org.cn
About this study
Official title: A Single Arm, Open-label, Phase II Study to Assess the Efficacy of Pamiparib in Metastatic Castration-Resistant Prostate Cancer Patients With Homologous Recombination Deficiency (HRD) or BRCA1/2 Mutation
The purpose of this study is to assess the efficacy of a PARP inhibitor, Pamiparib, in metastatic castration-resistant prostate cancer patients with homologous recombination deficiency or BRCA 1 or 2 somatic/germline mutation.
Read the detailed description
This is a single arm, open-label, single center, phase II trial, assessing the efficacy of a PARP inhibitor, Pamiparib, in 50 progressing metastatic castration-resistant prostate cancer patients with at least one line of androgen deprivation therapy or chemotherapy at the metastatic setting, and homologous recombination deficiency or BRCA 1 or 2 somatic or germline mutation.
- Being tested
- Pamiparib
- Keywords
- Metastatic Castration-resistant Prostate Cancer, PARP inhibitor, Homologous Recombination Deficiency, BRCA1/2 Mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamiparibDrug
Also called BGB-290
40 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Pamiparib | Experimental | Tablets 20mg per os : 40 mg / bid every day in continuous. Patients will be treated with Pamiparib. Cycles are defined in 28-day periods. Disease response will be assessed every 8 weeks (RECIST 1.1). Safety will be assessed continuously. Receives: Drug: Pamiparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic Progression-free Survival (rPFS)
Radiologic progression-free survival will be assessed from the time of the first dose to radiologic disease progression or death from any cause, whichever comes first.
Measured: 3 years
Secondary outcomes (8)
Objective Response Rate (ORR)
Proportion of patients in complete remission (CR) plus partial remission (PR)
Measured: From enrollment to primary completion of study (up to approximately 3 years)
Duration of Response (DOR)
Time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause.
Measured: From enrollment to primary completion of study (up to approximately 3 years)
Time to Response (TTR)
Time from initiation of treatment to first assessment of tumor as CR or PR.
Measured: From enrollment to primary completion of study (up to approximately 3 years)
Clinical Benefit Rate
according to RECIST, is either complete response (CR), partial response (PR) or stable disease (SD) lasting for at least 16 weeks
Measured: 3 years
Prostate Specific Antigen (PSA) Response Rate
Proportion of patients with a 50% decrease in PSA from baseline
Measured: From enrollment to primary completion of study (up to approximately 3 years)
Time to PSA Progression
Time from initiation of treatment to two consecutive 50% PSA increases from baseline level
Measured: From enrollment to primary completion of study (up to approximately 3 years)
Overall Survival (OS)
Time between the start of treatment and death from any cause
Measured: From enrollment to primary completion of study (up to approximately 3 years)
Adverse events
Adverse events are graded according to the CTCAE V4.03
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
- Investigators
- Fangjian Zhou, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327621
- Sponsor's protocol ID
- 2021-FXY-385
- Status last verified
- Apr 2022
- First submitted
- 27 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label, Phase II Study to Assess the Efficacy of Pamiparib in Metastatic Castration-Resistant Prostate Cancer Patients With Homologous Recombination Deficiency (HRD) or BRCA1/2 Mutation
- ClinicalTrials.gov ID
- NCT05327621
- Acronym / sponsor ID
- 2021-FXY-385
- Keywords
- Metastatic Castration-resistant Prostate Cancer, PARP inhibitor, Homologous Recombination Deficiency, BRCA1/2 Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of a PARP inhibitor, Pamiparib, in metastatic castration-resistant prostate cancer patients with homologous recombination deficiency or BRCA 1 or 2 somatic/germline mutation.
Detailed description
This is a single arm, open-label, single center, phase II trial, assessing the efficacy of a PARP inhibitor, Pamiparib, in 50 progressing metastatic castration-resistant prostate cancer patients with at least one line of androgen deprivation therapy or chemotherapy at the metastatic setting, and homologous recombination deficiency or BRCA 1 or 2 somatic or germline mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pamiparib | Experimental | Drug: PamiparibTablets 20mg per os : 40 mg / bid every day in continuous. Patients will be treated with Pamiparib. Cycles are defined in 28-day periods. Disease response will be assessed every 8 weeks (RECIST 1.1). Safety will be assessed continuously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ≥18 years old, male
- Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma without neuroendocrine differentiation of the prostate. Mixed histology is accepted, except for small cell carcinoma.
- Have a deleterious mutation in BRCA1/2 , or HRD score ≥ 9.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- BPI<4
Key exclusion criteria (14 listed)
- Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- Acute toxicity (CTCAE > grade 2) due to prior cancer therapy.
- Received chemotherapy, endocrine therapy, biotherapy, radionuclide therapy, immunotherapy, experimental drugs, proprietary anticancer drugs or Chinese herbal medicines within 5 (if known) half-lives or 14 days(if unknown) prior to the first day of taking Pamiparib; For bisphosphonates or approved bone targeting therapy, Pamiparib must be administered at a steady dose for ≥28 days prior to the first day of taking Pamiparib.
- Received radiation therapy within 21 days.
- Prior treatment with any PARP inhibitor. Prior chemotherapy with mitoxantrone or platinum-based chemotherapy or cyclophosphamide. Prior treatment with sipuleucel-T or immune check point inhibitors are allowed.
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 |
|---|---|---|
| PamiparibAlso: BGB-29040 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops. | Drug | Pamiparib |
Primary outcome
Radiologic Progression-free Survival (rPFS)
Time frame: 3 years
Radiologic progression-free survival will be assessed from the time of the first dose to radiologic disease progression or death from any cause, whichever comes first.
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Duration of Response (DOR)
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Time to Response (TTR)
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Clinical Benefit Rate
Time frame: 3 years
Prostate Specific Antigen (PSA) Response Rate
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Time to PSA Progression
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Overall Survival (OS)
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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Pluvicto Real-world Investigation in Survival in Metastatic CRPC
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Metastatic Castrate Resistant Prostate Cancer (mCRPC)
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.
Fangjian Zhou, M.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pamiparib in people with Metastatic Castration-resistant Prostate Cancer, run by Sun Yat-sen University at 1 site in China.
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 14 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangjian Zhou, M.D. (020-87343656, zhoufj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiologic Progression-free Survival (rPFS) (time frame: 3 years). 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 14 Apr 2022.