A Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Morphotek
- 入组人数
- 58
- 试验地点
- 19
- 主要终点
- Serologic Response (Change in CA125 Level)
研究概览
简要总结
The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.
详细描述
MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) either alone or in combination with other drugs. MORAb-003 works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if MORAb-003 can work either as a single agent
- to treat a CA125-only relapse, or
- in combination with standard platinum and taxane chemotherapy to treat a symptomatic relapse, and
- to prolong a second response to chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Female subjects at least 18 years of age, with a histologically confirmed diagnosis of non-mucinous epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) in first relapse after a first remission of 6 to 18 months duration.
- •Subjects must have undergone surgery. Subjects must have received primary chemotherapy, including at least one platinum agent.
- •Subject is eligible for retreatment with the same chemotherapy regimen that was used to induce remission (Exception: may reduce the dose of or discontinue taxane if contraindicated due to neurotoxicity.)
- •CA125 must have been elevated prior to original chemotherapy.
- •CA125 must be elevated at the time of relapse.
- •Life expectancy greater than or equal to 6 months, as estimated by the investigator.
- •Eastern Cooperative Oncology Group performance status of 0, 1 or 2
- •Subjects must consent to use a medically acceptable method of contraception throughout the study period and for 28 days after final MORAb-003 administration, unless surgically sterile.
- •Any significant concomitant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day
- •Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
- •Absolute neutrophil count (ANC) ≥ 1.2 x 10e9/L
- •Platelet count ≥ 100 x 10e9/L
- •Hemoglobin ≥ 8 g/dL
- •Subject must be willing and able to provide written informed consent. Translations of informed consent information may be provided, subject to the local institutional review board's (IRB's) policy.
排除标准
- •Known central nervous system (CNS) tumor involvement.
- •Evidence of other active malignancy requiring treatment.
- •Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
- •Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Exception: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible).
- •Active serious systemic disease, including active bacterial or fungal infection.
- •Active hepatitis or HIV infection.
- •Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, interleukin 1 receptor antagonist [IL-1RA] or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.
- •Treatment with a monoclonal antibody therapy AND have evidence of an immune or allergic reaction or documented HAHA.
- •Maintenance of first remission by taxane or other chemotherapeutic agent(s).
- •Initiation or planned initiation of cancer therapy not given to induce primary remission. Substitutions of agents materially similar to those used in the original regimen are permissible.
- •Breast-feeding, pregnant, or likely to become pregnant during the study.
研究组 & 干预措施
Far Only
Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
干预措施: Farletuzumab (Drug)
Chemo Plus Far
Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
干预措施: Chemo Plus Far (Drug)
结局指标
主要结局
Serologic Response (Change in CA125 Level)
时间窗: Baseline to response (up to 30 weeks)
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).
Serologic Response (Change in Cancer Antigen [CA-125] Level)
时间窗: Baseline to response (up to 27 weeks)
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).
次要结局
- Overall Response Rate(Baseline to response (up to 44 months))
- Progression-free Survival (PFS)(Baseline to response (up to 44 months))
- Time to Serologic Response (Change in CA-125 Level)(Baseline to response (up to 27 weeks))
- Percentage of Participants Who Had a Prolongation of Remission(Baseline to response (up to 44 months))
- Duration of Serologic Response (CA-125)(Baseline to response (up to 44 months))