NL-OMON30586已完成2 期
A Study of the Efficacy of MORAb-003 in Subjects with Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse - MORAb-003-002
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Female subjects, * 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.
- •2. Subjects must have undergone surgery. Subjects must have received primary chemotherapy, including at least one platinum agent.
- •3. 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.)
- •4. CA125 must have been elevated prior to original chemotherapy.
- •5. CA125 must be elevated at the time of relapse.
- •6. Life expectancy * 6 months, as estimated by the investigator.
- •7. Eastern Cooperative Oncology Group performance status or 0, 1 or 2 (see Appendix D).
- •8. 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.
- •9. 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 1.
- •10. Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
- •Absolute neutrophil count (ANC) * 1.2 x 109/L
- •Platelet count * 100 x 109/L
- •Hemoglobin * 8 g/dL
- •13. Subject must be willing and able to provide written informed consent. Translations of informed consent information may be provided, subject to the local IRB*s policy.
排除标准
- •1. Known central nervous system (CNS) tumor involvement.
- •2. Evidence of other active malignancy requiring treatment.
- •3. 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).
- •4. ECG demonstrating clinically significant arrhythmias (Exception: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
- •5. Active serious systemic disease, including active bacterial or fungal infection.
- •6. Active hepatitis or HIV infection.
- •7. Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, IL-1RA or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.
- •8. Treatment with a monoclonal antibody therapy AND have evidence of an immune or allergic reaction or documented HAHA.
- •9. Maintenance of first remission by taxane or other chemotherapeutic agent(s).
- •10. 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.
- •11. Breast-feeding, pregnant, or likely to become pregnant during the study.
研究者
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