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Investigating Safety, 耐受性, Efficacy and PK of Olaparib in Paediatric Patients With Solid Tumours
关于
简短的总结
A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours.
Primary Purpose
研究类型
阶段
资格
性别
Healthy Volunteers
最低年龄
最高年龄
Key Inclusion Criteria:
- Provision of Informed Consent
- Male and female patients who are ≥6 months to <18 years of age at consent
- Pathologically confirmed relapsed or refractory solid or primary CNS tumours (excluding lymphoid malignancies), with a HRR deficiency/gene mutation, and for whom there are no standard treatment options. Eligible patients may include but not be limited to those with osteosarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, 尤因肉瘤, 神经母细胞瘤, medulloblastoma and glioma
- For dose finding phase only: recruitment will be open to all patients with HRR deficiency, based on a local test. For the signal identification phase: recruitment will be open only to patients with documented evidence of a deleterious or suspected deleterious germline or tumour HRR gene mutation that meets the AZ HRR rules
- A formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer (all patients) suitable for central HRR testing and a blood sample (patients ≥2 years old) for central germline BRCA testing must be provided for each patient
- For all non-神经母细胞瘤 tumours, patients must have at least 1 radiographical assessable lesion (measurable and/or non-measurable). For 神经母细胞瘤 tumours, patients must have radiographical assessable disease with at least 1 lesion (measurable and/or non measurable) OR disease evidenced by uptake of meta-iodobenzylguanidine- (MIBG) or fluorodeoxyglucose positron emission tomography (FDG-PET) scans
- Adequate performance status, 器官, and marrow function and adequate weight to obtain blood samples for both safety laboratory assessments and PK analysis.
- Ability to swallow tablets
Key Exclusion Criteria:
- Patients with MDS/AML or with features suggestive of MDS/AML
- Patients unable to swallow orally administered medication
- Unresolved toxicity from previous anticancer therapy
- Unstable or untreated CNS disease (i.e., symptomatic uncontrolled brain metastases or untreated spinal cord compression)
- Previous treatment with a PARP inhibitor, including olaparib
- Receipt of any radiotherapy for cancer treatment (except for palliative reasons) within 30 days prior to first dose of study treatment or receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, monoclonal antibodies, etc) within 21 days prior to the first dose of study treatment
- Concomitant use of known strong or moderate CYP3A inhibitors or concomitant use of known strong or moderate CYP3A inducers
- Whole blood transfusions in the last 120 days prior to screening (packed red blood cells and platelet transfusions are acceptable)
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研究统计数据
协议没有.
23-5086
类别
脑癌
肾癌
肝癌
其他癌症
肉瘤
Principal Investigator
联系
位置
- 皇冠hga025大学洛杉矶分校韦斯特伍德