NCT01650376Unknown1 期
Phase Ib With Expansion of Patients at the MTD Study of Olaparib Plus Weekly (Metronomic) Carboplatin and Paclitaxel in Relapsed Ovarian Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Incidence of Dose Limiting Toxicity (DLT)
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose (MTD) of the investigational agent, olaparib, to give in combination with carboplatin and paclitaxel in patients with relapsed ovarian cancer or uterine cancer. Furthermore, the investigators intend to study the safety and tolerability of the study treatment, response to treatment, time to disease progression, and overall survival.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Advanced (stage III or IV), histologically or cytologically documented ovarian cancer or serious uterine cancer patients who relapsed after primary therapy with a platinum and a taxane. This includes:
- •Platinum sensitive: relapsed at least 6 months following platinum treatment
- •Platinum refractory: the cancer grew while on platinum treatment
- •Platinum resistant: recurrence within 6 months of platinum treatment
- •Must have failed first line treatment
- •ECOG performance status 0-2
- •Must be able to swallow and retain oral medication
- •Life expectancy greater than 16 weeks
- •Must have normal organ and bone marrow function defined as follows:
- •Hemoglobin ≥ 9.0 g/dL
- •Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- •White blood cells (WBC) > 3 x 10^9/L
- •Platelet count ≥ 100 10^9/L
- •Total bilirubin ≤ 1.5 x institutional upper limit of normal
- •AST (SGOT)/ALT (SGPT) ≤ x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5 ULN
- •Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
排除标准
- •Any previous treatment with a PARP inhibitor, including olaparib
- •Any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or longer period depending on the defined characteristics of the agents used)
- •Currently receiving the following classes of inhibitors of CYP3A4: azole antifungals, macrolide antibiotics, and protease inhibitors
- •Second primary cancer except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
- •Symptomatic uncontrolled brain metastases
- •Major surgery within 2 weeks of starting study treatment
- •Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
- •Known active hepatic disease (i.e. Hepatitis B or C)
- •Uncontrolled seizures
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin or paclitaxel
研究组 & 干预措施
Olaparib plus carboplatin and paclitaxel
Experimental
干预措施: Olaparib (Drug)
Olaparib plus carboplatin and paclitaxel
Experimental
干预措施: Carboplatin (Drug)
Olaparib plus carboplatin and paclitaxel
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Incidence of Dose Limiting Toxicity (DLT)
时间窗: 1 cycle (1 cycle = 28 days)
次要结局
- Number of Reported Adverse Events(Weekly assessments of clinical and laboratory values, and vital sign measurements performed while receiving study treatment. (Anticipated time of 6 months))
研究者
研究点 (5)
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