EUCTR2017-003552-23-ES进行中（未招募）1 期
A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer - 64091742PCR2002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Subjects of age 18 years or older
- •2. Willing to undergo all protocol-specified biopsies
- •3. Diagnosis of prostate adenocarcinoma as confirmed by the investigator.
- •4. Must have determination of biomarker status (either biomarker-positive [BM+] or biomarker–negative [BM-] by the sponsor’s blood-based assay
- •5. Subjects must have measurable disease as defined by RECIST 1.1 (soft tissue lesion of =10mm in the long axis or extrapelvic lymph node of =15mm in the short axis).
- •6. Must have previously received at least 1, but no more than 2, lines of novel AR-targeted therapy (eg, abiraterone acetate with prednisone, enzalutamide, apalutamide) for prostate cancer. Subjects must have had at least 4 weeks of AR-targeted therapy
- •7. Must have castrate levels of testosterone =50 ng/dL on a gonadotropin releasing hormone analogue (GnRHa), or history of bilateral orchiectomy at study entry
- •8. Progression of metastatic prostate cancer at study entry defined as having one or more of the following:
- •a. PSA progression defined by a minimum of 2 rising PSA levels with an interval of =1 week between each determination (per Prostate Cancer Working Group 3 [PCWG3] criteria). The PSA level at the screening visit should be =2 µg/L (2 ng/mL).
- •b. Radiographic progression by bone scan per PCWG3 or by soft tissue per RECIST 1.1.
- •9. Must be willing to continue GnRHa during the study if not surgically castrate.
- •10. Eastern Cooperative Oncology Group Performance Score (ECOG PS) Grade of 0 or 1
- •11. Subjects who received prior therapy with an anti-androgen (eg, bicalutamide, flutamide, nilutamide, abiraterone acetate with prednisone, enzalutamide, apalutamide) must have at least a 4-week washout prior to enrollment.
- •12. To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must agree while on study drugs and for 5 months following the last dose of study drugs to:
- •a.Use a condom during sexual activity.
- •b.Not donate sperm.
- •13. Clinical laboratory values at Screening:
- •a.Absolute neutrophil count (ANC) =1.5 x 10^9/L, independent of growth factors for 30 days
- •b.Hemoglobin =9.0 g/dL, independent of growth factors or transfusions for 30 days
- •c.Platelet count =100 x 10^9/L, independent of growth factors or transfusions for 30 days
- •d.Serum albumin =3.0 g/dL
- •e.Creatinine clearance =30 mL/min/1.73 m^2 either calculated or directly measured via 24-hour urine collection
- •f.Serum total bilirubin =1.5 x upper limit of normal (ULN) or direct bilirubin =1 x ULN (Note: in subjects with Gilbert’s syndrome, if total bilirubin is >1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is =1.5 x ULN, subject may be eligible as determined by the medical monitor)
- •g.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =3 x ULN
- •h.Fasting glucose =250 mg/dL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1. Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor.
- •2. History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
- •3. Active malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently remission) =2 years prior to enrollment.
- •4. Active infection requiring systemic therapy.
- •5. Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients (refer to the Investigator’s Brochures).
- •6. Human immunodeficiency virus (HIV)-positive subjects 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 11.c, a change is made to avoid a potential drug-drug interaction with the study drug).
- •c. Receiving antiretroviral therapy that may interfere with the study drug
- •(consult the sponsor for review of medication prior to enrollment).
- •d. CD4 count <350 cells/mm^3 at screening.
- •e. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.
- •7. Active hepatitis B virus (eg, hepatitis B surface antigen reactive) or active hepatitis C virus (HCV) (eg, HCV ribonucleic acid [RNA] [qualitative] is detected).
- •8. If a subject has undergone major surgery, they must have recovered adequately from the toxicities or complications from the intervention prior to starting therapy.
- •9. Prior radium treatment or treatment with other therapeutic radiopharmaceuticals for prostate cancer.
- •10. Any of the following =30 days prior to planned Cycle 1 Day 1:
- •a.A transfusion (platelets or red blood cells).
- •b.Hematopoietic growth factors.
- •c.An investigational agent for prostate cancer.
- •d.Major surgery (sponsor's medical monitor should be consulted regarding what constitutes major surgery).
- •e.Radiation therapy
- •11. Symptomatic brain metastasis from prostate cancer.
- •12. Symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, or uncontrolled hypertension.
- •13. Any condition for which, in the opinion of the investigator or medical monitor, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •For excl.criteria to combination 1: Niraparib and JNJ63723283:
- •1. Prior treatment with sipuleucel-T.
- •2. Prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody (including any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •3. Subjects with a history of allergy to protein-based therapies or any significant drug allergy (ie, analphylaxis, heptatotoxicity, or immune-mediated thrombocytopenia or anemia).
- •4. History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis.
- •5. Allergies, hypersensitivity, or intolerance to JNJ-63723283 or the corresponding excipients (refer to the Investigator’s Brochure).
- •6. Immunodeficiency or receiving systemic corticosteroid therapy or immunosuppressive therapy (eg, cyclosporine) within 7 days prior to treatment allocation. The use of physiologic doses of corticosteroids may be approved after consultation with the
研究者
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