計劃書編號IMP4297-202
2021-06-01 - 2022-05-30
Phase II
召募中6
ICD-10Z85.46
攝護腺惡性腫瘤之個人史
ICD-9V10.46
攝護腺惡性腫瘤病史
一項隨機分配、雙盲、安慰劑對照、多中心、第II期試驗，在具有同源重組修復基因變化之轉移性去勢抗性前列腺癌患者中，評估於docetaxel治療後以Senaparib作為維持治療
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
IMPACT Therapeutics, Inc.
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臨床試驗規模
多國多中心
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更新日期
2025/08/20
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
轉移性去勢抗性前列腺癌
試驗目的
主要
針對具有乳癌易感基因[BRCA] 1/2 基因變化且由盲性獨立中央審查委員會(BICR)評估，於docetaxel 治療後未惡化之轉移性去勢抗性前列腺癌(mCRPC)病患中，相較於安慰劑，評估Senaparib 維持治療對於放射影像無惡化存活期(rPFS)的影響
藥品名稱
Senaparib (IMP4297)
主成份
Senaparib
劑型
Capsule
劑量
20
評估指標
Primary Outcome Measure:
1. rPFS assessed by BICR
To evaluate the impact of Senaparib on radiographic progression free survival (rPFS), compared with the placebo, in metastatic castration-resistant prostate cancer (mCRPC) patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy assessed by Blinded Independent Central Review (BICR).
[Time Frame: 80 weeks]
Secondary Outcome Measure:
2. rPFS assessed by BICR
To evaluate the impact of Senaparib on rPFS, compared with the placebo, in mCRPC patients with homologous recombination repair (HRR) gene alterations who have not progressed after docetaxel therapy assessed by BICR.
[Time Frame: 80 weeks]
3. Time to pain progression
To evaluate the impact of Senaparib on time to pain progression, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
4. Time from randomization to the first SSRE
To evaluate the impact of Senaparib on time to the first symptomatic skeletal related events (SSRE), compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
5. OS
To evaluate the impact of Senaparib on overall survival (OS), compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
6. PFS2
To evaluate the impact of Senaparib on second progression (PFS2), compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
7. Time to pain progression
To evaluate the impact of Senaparib on time to pain progression, compared with the placebo, in mCRPC patients with HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
8. Time from randomization to the first SSRE
To evaluate the impact of Senaparib on time to the first SSRE, compared with the placebo, in mCRPC patients with HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
9. OS
To evaluate the impact of Senaparib on OS, compared with the placebo, in mCRPC patients with HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
10. rPFS assessed by the investigator
To evaluate the impact of Senaparib on rPFS assessed by the investigator, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
11. Time to PSA progression
To evaluate the impact of Senaparib on time to prostate-specific antigen (PSA) progression, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
12. Objective response rate (ORR) according to RECIST v1.1 assessed by BICR
To evaluate the impact of Senaparib on radiographic response rate assessed by BICR, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have measurable lesion and have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
13. Objective response rate (ORR) according to RECIST v1.1 assessed by investigator
To evaluate the impact of Senaparib on radiographic response rate assessed by the investigator, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have measurable lesion and have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
14. PSA response rate according to PCWG3 criteria assessed by central laboratory
To evaluate the impact of Senaparib on PSA response rate, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
15. Safety endpoints
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0.
[Time Frame: 80 weeks]
16. plasma PK profile
To characterize the plasma PK profile of Senaparib via population PK (popPK) modeling
[Time Frame: 80 weeks]
1. rPFS assessed by BICR
To evaluate the impact of Senaparib on radiographic progression free survival (rPFS), compared with the placebo, in metastatic castration-resistant prostate cancer (mCRPC) patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy assessed by Blinded Independent Central Review (BICR).
[Time Frame: 80 weeks]
Secondary Outcome Measure:
2. rPFS assessed by BICR
To evaluate the impact of Senaparib on rPFS, compared with the placebo, in mCRPC patients with homologous recombination repair (HRR) gene alterations who have not progressed after docetaxel therapy assessed by BICR.
[Time Frame: 80 weeks]
3. Time to pain progression
To evaluate the impact of Senaparib on time to pain progression, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
4. Time from randomization to the first SSRE
To evaluate the impact of Senaparib on time to the first symptomatic skeletal related events (SSRE), compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
5. OS
To evaluate the impact of Senaparib on overall survival (OS), compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
6. PFS2
To evaluate the impact of Senaparib on second progression (PFS2), compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
7. Time to pain progression
To evaluate the impact of Senaparib on time to pain progression, compared with the placebo, in mCRPC patients with HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
8. Time from randomization to the first SSRE
To evaluate the impact of Senaparib on time to the first SSRE, compared with the placebo, in mCRPC patients with HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
9. OS
To evaluate the impact of Senaparib on OS, compared with the placebo, in mCRPC patients with HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
10. rPFS assessed by the investigator
To evaluate the impact of Senaparib on rPFS assessed by the investigator, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
11. Time to PSA progression
To evaluate the impact of Senaparib on time to prostate-specific antigen (PSA) progression, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
12. Objective response rate (ORR) according to RECIST v1.1 assessed by BICR
To evaluate the impact of Senaparib on radiographic response rate assessed by BICR, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have measurable lesion and have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
13. Objective response rate (ORR) according to RECIST v1.1 assessed by investigator
To evaluate the impact of Senaparib on radiographic response rate assessed by the investigator, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have measurable lesion and have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
14. PSA response rate according to PCWG3 criteria assessed by central laboratory
To evaluate the impact of Senaparib on PSA response rate, compared with the placebo, in mCRPC patients with BRCA1/2 gene alteration and HRR gene alterations who have not progressed after docetaxel therapy.
[Time Frame: 80 weeks]
15. Safety endpoints
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0.
[Time Frame: 80 weeks]
16. plasma PK profile
To characterize the plasma PK profile of Senaparib via population PK (popPK) modeling
[Time Frame: 80 weeks]
主要納入條件
Inclusion Criteria:
1. Patients must voluntarily participate in this clinical study. Be willing written informed consent form (ICF) prior to any study activity.
2. Male ≥18 years of age on the day of signing the ICF.
3. Patients must have histologically or cytologically confirmed prostate adenocarcinoma.
4. Surgically or medically castrated, with serum testosterone levels of ≤50 ng/dL (≤1.73 nmol/L). If the patient is being treated with LHRH agonists/antagonists (patient who have not undergone orchiectomy), this therapy must be continued throughout the study.
5. Patients have adequate organ functions, as indicated by the following laboratory values (had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), and other relevant medical support within 14 days before the administration of study drug).
6. Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7. Male patients must use a condom during treatment and for 3 months after the last dose of study drug when having sexual intercourse with a woman of childbearing potential. Female partners of male patients should also use an acceptable method of contraception if they are of childbearing potential.
Exclusion Criteria:
1. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
2. Prior treatment with a polyadenosine 5’diphosphoribose polymerisation (PARP) inhibitor, including Senaparib.
3. Patients with a known hypersensitivity to Senaparib or any of the component of Senaparib.
4. Initiating bisphosphonate/denosumab therapy or adjusting bisphosphonate/denosumab dose/regimen within 28 days prior to the first dose of study drug. Patients on a stable bisphosphonate/denosumab regimen are eligible and may continue.
5. Patients who have received strong inhibitors/inducers of CYP3A4 which cannot be discontinued 21 days prior to the first dose of study drug and withheld throughout the study drug treatment. Patients received phenobarbital/enzalutamide will require a 5-week washout prior to the first dose of study drug.
6. Patients with MDS or AML, or with clinical features suggestive of MDS or AML.
7. Patients with serious acute or chronic infections.
8. Patients who have received a live virus or bacterial or RNA vaccination within 28 days prior to the first dose of study drug.
9. Patients are unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
1. Patients must voluntarily participate in this clinical study. Be willing written informed consent form (ICF) prior to any study activity.
2. Male ≥18 years of age on the day of signing the ICF.
3. Patients must have histologically or cytologically confirmed prostate adenocarcinoma.
4. Surgically or medically castrated, with serum testosterone levels of ≤50 ng/dL (≤1.73 nmol/L). If the patient is being treated with LHRH agonists/antagonists (patient who have not undergone orchiectomy), this therapy must be continued throughout the study.
5. Patients have adequate organ functions, as indicated by the following laboratory values (had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), and other relevant medical support within 14 days before the administration of study drug).
6. Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7. Male patients must use a condom during treatment and for 3 months after the last dose of study drug when having sexual intercourse with a woman of childbearing potential. Female partners of male patients should also use an acceptable method of contraception if they are of childbearing potential.
Exclusion Criteria:
1. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
2. Prior treatment with a polyadenosine 5’diphosphoribose polymerisation (PARP) inhibitor, including Senaparib.
3. Patients with a known hypersensitivity to Senaparib or any of the component of Senaparib.
4. Initiating bisphosphonate/denosumab therapy or adjusting bisphosphonate/denosumab dose/regimen within 28 days prior to the first dose of study drug. Patients on a stable bisphosphonate/denosumab regimen are eligible and may continue.
5. Patients who have received strong inhibitors/inducers of CYP3A4 which cannot be discontinued 21 days prior to the first dose of study drug and withheld throughout the study drug treatment. Patients received phenobarbital/enzalutamide will require a 5-week washout prior to the first dose of study drug.
6. Patients with MDS or AML, or with clinical features suggestive of MDS or AML.
7. Patients with serious acute or chronic infections.
8. Patients who have received a live virus or bacterial or RNA vaccination within 28 days prior to the first dose of study drug.
9. Patients are unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
試驗計畫預計收納受試者人數
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台灣人數
68 人
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全球人數
660 人
