EUCTR2015-004005-16-GB进行中（未招募）1 期
A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Olaparib (PARP inhibitor) in Patients with Advanced Solid Tumors - AstraZeneca D081KC00001
Astra Zeneca AB0 个研究点目标入组 886 人开始时间: 2015年12月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 886
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
- All
入选标准
- •Inclusion criteria are presented separately for each cohort of Modules 1
- •Small cell lung cancer cohort:
- •Patients must have histologically or cytologically confirmed progressive
- •metastatic or recurrent solid tumor (as defined below for each tumor
- •type). To be enrolled in the SCLC cohort, only the tumor types and
- •settings described below are allowed (see in the Protocol)
- •At least 1 measurable lesion that can be accurately assessed at baseline
- •by computed tomography (CT) (or magnetic resonance imaging [MRI]
- •where CT is contraindicated) and is suitable for repeated assessment as
- •per RECIST 1.1. The baseline scan must be obtained
- •within 28 days prior to the first dose of olaparib. Biomarker-only disease
- •is not considered evaluable.
- •Breast cancer cohort:
- •Patients must have histologically or cytologically confirmed progressive
- •metastatic or recurrent solid tumor (as defined below for each tumor
- •type). To be enrolled in the gBRCAm breast cancer cohort, only the
- •tumor types and settings described below are allowed (see in the
- •At least 1 measurable lesion that can be accurately assessed at baseline
- •by computed tomography (CT) (or magnetic resonance imaging [MRI]
- •where CT is contraindicated) and is suitable for repeated assessment as
- •per RECIST 1.1. The baseline scan must be obtained
- •within 28 days prior to the first dose of olaparib. Biomarker-only disease
- •is not considered evaluable.
- •gBRCAm human epidermal growth factor receptor 2 (HER2)-negative
- •breast cancer patients with metastatic or locally advanced disease,
- •which is unresectable (or the patient is not a candidate for resection),
- •may be first, second or third line but all patients must meet the following
- •specific criteria:
- •Must have confirmation of a germline mutation in BRCA1 or BRCA2 that
- •is predicted to be deleterious or suspected deleterious (known or
- •predicted to be detrimental/lead to loss of function).
- •Must have previously received treatment with an anthracycline (eg,
- •doxorubicin, epirubicin) unless contraindicated and/or a taxane (eg,
- •paclitaxel, docetaxel) in either a neo-adjuvant/adjuvant or metastatic
- •gBRCAm ovarian cancer cohort:
- •Patients must have histologically or cytologically confirmed progressive
- •metastatic or recurrent solid tumor (as defined below for each tumor
- •type). To be enrolled in the gBRCAm ovarian cancer cohort, only the
- •tumor types and settings described below are allowed (see in
- •the Protocol).
- •At least 1 measurable lesion that can be accurately assessed at baseline
- •by computed tomography (CT) (or magnetic resonance imaging [MRI]
- •where CT is contraindicated) and is suitable for repeated assessment as
- •per RECIST 1.1. The baseline scan must be obtained
- •within 28 days prior to the first dose of olaparib. Biomarker-only
- •disease is not considered evaluable.
- •non-gBRCA ovarian cancer
- •High grade serous ovarian cancer (including patients with primary
- •peritoneal and/or fallopian tube cancer) with recurrent disease and:
- •Previously received 1 or 2 previous lines of chemotherapy, including =1
- 另有 8 项未显示
排除标准
- •Exclusion criteria are presented separately for each cohort in Modules 1
- •Small cell lung cancer cohort:
- •Prior chemotherapy or other systemic anticancer therapy (eg, targeted
- •biotherapy or hormonal agents) within 4 weeks prior to start of olaparib
- •treatment; 6 weeks for nitrosoureas or mitomycin. Exceptions and
- •treatments of particular importance are noted below (see Protocol)
- •Radiation therapy within 4 weeks prior to start of olaparib treatment
- •(includes radiation targeting bone metastases) or radionuclide
- •treatment within 6 weeks of treatment start.
- •Patients with mixed small cell and non-small cell lung cancer histology.
- •Breast cancer cohort:
- •Prior chemotherapy or other systemic anticancer therapy (eg, targeted
- •biotherapy or hormonal agents) within 4 weeks prior to start of olaparib
- •treatment; 6 weeks for nitrosoureas or mitomycin. Exceptions and
- •treatments of particular importance are noted below (see the Protocol).
- •Radiation therapy within 4 weeks prior to start of olaparib treatment
- •(includes radiation targeting bone metastases) or radionuclide
- •treatment within 6 weeks of treatment start.
- •Patients with HER2-positive disease (3+ by immunohistochemistry [IHC]
- •or in situ hybridization amplified =2.0).
- •Patients cannot have received more than 2 prior lines of cytotoxic
- •chemotherapy for metastatic disease. Prior treatments with hormonal
- •therapy and non-hormonal targeted therapy are allowed and not counted
- •as a prior line of cytotoxic chemotherapy. For the purposes of this
- •protocol, the combination of an aromatase inhibitor and everolimus or
- •palbociclib, are not considered cytotoxic chemotherapy.
- •BRCA1 and/or BRCA2 variants that are considered to be non-detrimental
- •(eg, Variants of uncertain clinical significance or Variant of unknown
- •significance or Variant, favor polymorphism or benign
- •polymorphism etc).
- •gBRCAm ovarian cancer cohort:
- •Prior chemotherapy or other systemic anticancer therapy (eg, targeted
- •biotherapy or hormonal agents) within 4 weeks prior to start of olaparib
- •treatment; 6 weeks for nitrosoureas or mitomycin. Exceptions and
- •treatments of particular importance are noted below (see in the
- •Radiation therapy within 4 weeks prior to start of olaparib treatment
- •(includes radiation targeting bone metastases) or radionuclide
- •treatment within 6 weeks of treatment start.
- •Patients with germline BRCA1 and/or BRCA2 variants that are
- •considered to be non-detrimental (eg, Variants of uncertain clinical
- •significance or Variant of unknown significance or Variant, favor
- •polymorphism or benign polymorphism etc).
- •non-gBRCA ovarian
- •Patients with known germline BRCA1 and/or BRCA2 mutations, with the
- •exception of variants of uncertain clinical significance or Variant of
- •unknown significance or Variant, favor polymorphism or benign
- •polymorphism.
- •Gastric cancer cohort:
- •Prior chemotherapy or other systemic anticancer therapy (eg, targeted
- •biotherapy or hormonal agents) within 4 weeks prior to start of olaparib
- 另有 8 项未显示
研究者
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