NL-OMON52439招募中不适用
An open-label, randomized study to assess the relative bioavailability (BA) and bioequivalence (BE) of fixed-dose combination (FDC) formulations of niraparib plus abiraterone acetate (AA) compared to niraparib and AA co-administered as single agents in men with prostate cancer - 67652000PCR1001
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •2. >/= 18 years or older
- •3. Signed ICF, documenting that purpose and procedures are understood and
- •patient is willing to participate in study.
- •4. Histologically or cytologically confirmed adenocarcinoma of the prostate.
- •5.Diagnosed with mCRPC, who in the opinion of the investigator may benefit from
- •treatment in this study.
- •6.Able to continue gonadotropin-releasing hormone analogues (GnRHa) therapy
- •during the study if not surgically castrate (ie, participants who have not
- •undergone bilateral orchiectomy).
- •7.Criterion modified per Amendment 1.
- •7.1 Participants who received prior therapy with enzalutamide or apalutamide
- •must have at least an 8-week or a 6-week washout, respectively, before the
- •first dose of study treatment. Participants who received prior therapy with
- •other anti-androgens (eg, bicalutamide, flutamide, nilutamide) must have at
- •least a 2-week washout before the first dose of the study treatment.
- •8.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of <=1.
- •9.Toxicity associated with prior chemotherapy or radiotherapy has resolved to
- •Grade <=1 (except alopecia, local skin fibrosis/reaction or Grade <=2 neuropathy)
- •at screening.
- •10.At screening, the following laboratory parameters must be met:
- •a.Absolute neutrophil count (ANC) >=1.5x109/L
- •b.Hemoglobin >=9.0 g/dL independent of transfusion within the last 4 weeks
- •c.Platelet count >=100x109/L independent of transfusion within the last 4 weeks
- •d.Serum albumin >=3.0 g/dL
- •e.Serum creatinine <=1.5×upper limit of normal (ULN), or a calculated creatinine
- •clearance >=60 mL/min/1.73 m2 using the MDRD or Chronic Kidney Disease
- •Epidemiology Collaboration (CKD-EPI) equation
- •f.Serum potassium >=3.5 mmol/L
- •g.Serum total bilirubin <=1.5×ULN (Note: In participants with Gilbert*s
- •syndrome, if total bilirubin is >1.5×ULN, measure direct and indirect
- •bilirubin, and if direct bilirubin is <=1.5×ULN, participant may be eligible)
- •h.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <=3xULN
- •11. Criterion modified per Amendment 1.
- •11.1 While on study medication and for 3 months following the last dose of
- •study medication, a male participant must agree to use an adequate
- •contraception method as deemed appropriate by the investigator and as specified
- •in Protocol Section 5.3. Lifestyle Considerations.
- •12. Ability to provide a blood sample for determination of HRR gene alteration
- •13. Willing to provide a tumor sample (archival) for determination of HRR gene
排除标准
- •1.Symptomatic brain metastases.
- •2. Criterion modified per Amendment 1.
- •2.1 Prior disease progression during treatment with AA alone or when combined
- •with a PARP inhibitor (PARPi). Prior discontinuation of treatment with AA or
- •due to AA- or PARPi-related toxicity.
- •3.History or current diagnosis of MDS/AML.
- •4.Active malignancies (ie, progressing or requiring treatment change in the
- •last 24 months) other than the disease being treated under study. The only
- •allowed exceptions are:
- •a.non-muscle invasive bladder cancer.
- •b.skin cancer (non-melanoma or melanoma) treated within the last 24 months that
- •is considered completely cured.
- •c.Malignancy that is considered cured with minimal risk of recurrence.
- •5.Known allergies, hypersensitivity, or intolerance to niraparib or AA or the
- •corresponding excipients of niraparib/AA.
- •6. Any medical condition that would make prednisone use contraindicated.
- •7.Active hepatitis B virus (eg, hepatitis B surface antigen [HBsAg] reactive)
- •or active hepatitis C virus (HCV) (eg, HCV ribonucleic acid [RNA] [qualitative]
- •is detected).
- •8.Human immunodeficiency virus (HIV)-positive participants with 1 or more of
- •the following:
- •a.Not receiving highly active antiretroviral therapy
- •b.A change in antiretroviral therapy within 6 months of the start of screening
- •(except if, after consultation with the sponsor on exclusion criterion 15.c, a
- •change is made to avoid a potential drug-drug interaction with the study drug)
- •c.Receiving antiretroviral therapy that may interfere with study treatment
- •(consult the sponsor for review of medication prior to enrollment)
- •d. CD4 count < 350 at screening
- •e.An acquired immunodeficiency syndrome-defining opportunistic infection within
- •6 months of the start of screening
- •9 .<=21 days prior to Study Day 1 received or had
- •a. chemotherapy or immunotherapy for treatment of prostate cancer
- •b. investigational agent for treatment of prostate cancer
- •10. Active or symptomatic viral hepatitis or chronic liver disease; ascites or
- •bleeding disorders secondary to hepatic dysfunction.
- •11. Moderate or Severe hepatic impairment Class B or C per Child-Pugh
- •classification system.
研究者
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