EUCTR2017-004927-56-GB进行中（未招募）1 期
A Phase 1b/2, Open-label, Multicenter Dose-ranging Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SRA737 in Combination With Niraparib in Subjects With Metastatic Castration-resistant Prostate Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •Dose escalation and expansion cohorts:
- •1) Written informed consent prior to any trial specific procedures, sampling and analyses.
- •2) Attained the age of 18 years at the time consent is given.
- •3) Histologically or cytologically confirmed adenocarcinoma of the prostate.
- •4) Surgically or medically castrated, with serum testosterone levels of = 50 ng/dL (1.73 nM). For subjects currently being treated with luteinizing hormone-releasing hormone (LHRH) agonists and antagonists, therapy must be continued throughout the trial.
- •5) Prior treatment with at least 1 prior taxane containing regimen.
- •6) Prior treatment with at least 1 of the following: abiraterone acetate, enzalutamide, or investigational androgen receptor (AR)-targeted agent. A wash-out period of 4 weeks is required for subjects who received first and second generation anti-androgen therapy including enzalutamide and apalutamide.
- •7) Disease progression on or after most recent prior therapy for mCRPC; with disease progression in this context being based on any one of the following:
- •a. PSA progression as defined in Section 6.2.2 with a minimum of 2 consecutive rising levels taken 1 or more weeks apart (per PCWG3 criteria). Minimum starting value should be = 2 ng/mL. If confirmed rise is the only indication of progression, then the minimum starting value should be 1 ng/mL.
- •b. Radiographic progression of soft tissue by RECIST 1.1 or bone disease by PCWG3 criteria as defined in Appendix G in subjects with:
- •I. Soft tissue disease, measurable by RECIST 1.1 defined as having 1 or more of the following:
- •i. Nodal disease (pelvic or extrapelvic [retroperitoneal, mediastinal, thoracic, other]) with lesions = 1.5 cm in the short axis.
- •ii. Visceral disease (lung, liver, adrenal) with lesions = 1 cm in the long axis.
- •II. Bone disease (non-measurable) defined as having 2 or more new bone lesions in the absence of measurable soft tissue disease.
- •8) Life expectancy of at least 12 weeks.
- •9) Hematological and biochemical indices within the ranges shown below, measured within 1 week prior to the subject receiving their first dose of IMP (as listed in protocol table in the inclusion criteria).
- •10) World Health Organization (WHO) performance status 0-1 with no deterioration over the 2 weeks prior to trial entry.
- •11) Evaluable disease as demonstrated by any one of the following: A) Measurable disease per RECIST v1.1; B) Increasing PSA; or C) CTC count of = 5 cells/7.5 mL of blood.
- •Dose expansion cohort only:
- •12) At least 20 of the planned 31 subjects must have radiographically measurable disease per RECIST v1.1. The remaining subjects may be eligible by increasing PSA or CTC count of = 5 cells/7.5 mL of blood.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1) Any prior treatment with a Chk1 inhibitor, or prior treatment with an ATR inhibitor within 6 months prior to receiving the first dose of IMP.
- •2) Have received the following prior or current anticancer therapy:
- •a. Radiotherapy within 15 days prior to the first dose of IMP (except for symptom control and where the lesions will not be used as measurable disease)
- •b. Endocrine therapy within 3 weeks prior to the first dose of IMP (except for LHRH agonists and antagonists for prostate cancer)
- •c. Chemotherapy within 3 weeks prior to the first dose of IMP
- •d. Immunotherapy within 6 weeks prior to the first dose of IMP
- •e. Nitrosoureas or Mitomycin C within 6 weeks prior to the first dose of IMP
- •f. Other IMPs within 4 weeks prior to the first dose of IMP
- •3) Untreated brain or meningeal metastases that have not been stable (ie, asymptomatic and not progressing) for at least 8 weeks.
- •4) Symptomatic or impending spinal cord compression unless appropriately treated and clinically stable.
- •5) Initiated bisphosphonate or denosumab therapy or adjusted bisphosphonate or denosumab dose/regimen within 4 weeks prior to the first dose of IMP. Subjects on stable bisphosphonate or denosumab regimen are eligible and may continue treatment.
- •6) Other malignancy within the past 2 years with the exception of adequately treated tumors that are associated with an expected 5-year disease-free survival of approximately 95% or better.
- •7) Received a platelet transfusion or hematopoietic growth factors within 30 days prior to trial entry.
- •8) Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
- •9) Ongoing toxic manifestations of previous treatments greater than NCI-CTCAE Grade 1. Exceptions to this are alopecia or certain toxicities, which in the opinion of the investigator and the sponsor or sponsor’s designee monitor should not exclude the subject.
- •10) Subjects with partners of childbearing potential unless they agree to take measures not to father children by using a highly effective method of contraception. Subjects with pregnant or lactating partners must be advised to use a barrier method of contraception to prevent exposure of the fetus or neonate. Refer to for details.
- •11) Major surgery from which the subject has not yet recovered.
- •12) At high medical risk because of nonmalignant systemic disease including active uncontrolled infection.
- •13) Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- •14) Serious cardiac condition, such as concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA] refer to Appendix B), left ventricular ejection fraction < 45% at baseline, history of cardiac ischemia within the past 6 months, or prior history of significant cardiac arrhythmia requiring treatment unless approved by the sponsor.
- •15) Prior bone marrow transplant or extensive radiotherapy to greater than 25% of bone marrow within 8 weeks.
- •16) Peanut allergy unless this restriction is removed by the sponsor (refer to Section 5.1 for details).
- •17) QTcF > 450 msec.
- •18) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of IMP (eg, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- •19) Not able to swallow capsules without chewing or crushing. Pre-existing duodenal stent
研究者
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