NCT03009682已完成2 期
Phase II, Single-arm Study of Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 1/2 Mutations, ATM Deficiency or MRE11A Mutations(SUKSES-B)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) by RECIST 1.1
研究概览
简要总结
This study is a single arm, multi-center phase II study of olaparib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring HR pathway gene mutations not limited to BRCA 1/2 mutations, ATM deficiency or MRE11A mutations as second or third line chemotherapy.
Target subject population:
Patients with small cell lung cancer that have progressed following first-line platinum-based therapy. Patients must have imaging confirmed progression on 1st line chemotherapy for SCLC treatment, which must have contained platinum-based regimen, with at least one measurable lesion per RECIST 1.1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Small cell lung cancer that satisfies one or more of the following conditions:
- •BRCA1 or BRCA2 mutation, ATM deficiency, MRE11A mutation 2) Mutation of other HR(homologous recombination) pathway genes: BLM, NBN, RAD50, RAD52, RAD54L, RAD51, RAD51B, RAD51C, RAD51D, RECQL, RECQL4, RECQL5, RPA1, WRN etc.
- •Small cell lung cancer that has progressed during or after first-line therapy.
- •The 1st line regimen must have contained platinum based regimen.
- •Refractory to first-line chemotherapy or relapse within 6 months since the last dose of first-line chemotherapy
- •If the patient correspond to sensitive relapse (relapse more than 6 months since the last dose of first-line chemotherapy), she/he should get second- line treatment.
- •Patients (male/female) must be > 20 years of age.
- •Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- •ECOG performance status 0-1
- •Patients must have a life expectancy ≥ 16 weeks
- •Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1
- •Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •At least one lesion, not previously irradiated,
- •Provision of informed consent for genetic research.
排除标准
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •Previous enrolment in the present study
- •Participation in another clinical study with an investigational product during the last 2 weeks (or a longer period depending on the defined characteristics of the agents used).
- •Any previous treatment with a PARP inhibitor, including olaparib.
- •More than two prior chemotherapy regimen for the treatment of small cell lung cancer. Pazopanib maintenance or immune checkpoint inhibitor (CTLA4, PD-1 or PD-L1 monoclonal antibody) is not considered as line of treatment.
- •Patients with second primary cancer
- •Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
- •Concomitant use of known CYP3A4 inhibitors such as ketokonazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
- •Persistent toxicities (>=CTCAE grade 2) with the exception of alopecia, caused by previous cancer therapy.
- •Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- •Patients with myelodysplastic syndrome/acute myeloid leukaemia
- •Patients with symptomatic uncontrolled brain metastases.
- •Major surgery within 14 days of starting study treatment or patients not being recovered from any effects of any major surgery
- •Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- •Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •Breast feeding women
- •Immunocompromised patients,
- •Patients with known active hepatic disease (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
- •Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- •Patients with uncontrolled seizures.
研究组 & 干预措施
Olaparib 300 mg
Other
Olaparib 300 mg BID per os every 12 hours administered daily. One cycle is consisted of 21 days
干预措施: Olaparib (Drug)
结局指标
主要结局
Objective response rate (ORR) by RECIST 1.1
时间窗: Up to 30 months
次要结局
- Duration of response(Up to 30 months)
- Number of participants with Adverse Events as Assessed by CTCAE v4.03(Up to 30 months)
- Disease control rate(at 12 weeks)
- Overall survival (OS)(Up to 30 months)
- Progression-free survival (PFS)(Up to 30 months)
研究者
Keunchil Park
professor, MD
Samsung Medical Center
研究点 (1)
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