CTRI/2011/12/002296尚未招募3 期
A phase III multicenter, randomized, double-blind, double-dummy, active-controlled, parallel group study of the efficacy and safety of oral netupitant administered in combination with palonosetron and dexamethasone compared to oral palonosetron and dexamethasone for the prevention of nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,460
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
入选标准
- •1. Signed written informed consent. 2. Male or female patient greater or equal than 18 years of age. 3. Naïve to cytotoxic chemotherapy. Previous
- •biological or hormonal therapy will be permitted. 4. Scheduled to receive first course of an anthracycline and cyclophosphamide containing moderately emetogenic chemotherapy (MEC) regimen for the treatment of a solid malignant tumor: cyclophosphamide I.V. (500 to 1500 mg/m2)
- •and I.V. doxorubicin (greater or equal than 40 mg/m2) or cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. epirubicin (greater or equal than 60 mg/m2). 5. If scheduled to receive chemotherapy
- •agents of minimal to low emetogenic potential they could be given on any day. 6. ECOG Performance Status of 0, 1, or 2. 7. Female patients of either: a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is postmenopausal. For purposes of this study, postmenopausal is defined as 12 consecutive months of amenorrhea.The following inclusion criteria must be checked prior inclusion at each
- •cycle of the Multiple-Cycle Extension: 1. Participation in the study during the next cycle of chemotherapy is considered appropriate by the investigator and does not pose unwarranted risk to the patient. 2. Satisfactory study compliance in the preceding cycle of chemotherapy and related study procedures. 3. Scheduled to receive the same chemotherapy regimen as cycle 1 as defined in Inclusion Criterion n. 4.
- •4. Adequate hematologic and metabolic status as defined by Inclusion Criterion n. 8.
排除标准
- •1. If female, pregnant or lactating. 2. Current use of illicit drugs or current evidence of alcohol abuse. 3. Scheduled to receive any highly
- •emetogenic chemotherapy (HEC) from Day 1 to Day 5 or moderately emetogenic chemotherapy (MEC) from Day 2 to Day 5 following the allowed MEC regimen. 4. Received or is scheduled to receive radiation
- •therapy to the abdomen or the pelvis within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1. 5.Any vomiting, retching, or mild nausea
- •(grade greater or equal than I as defined by National Cancer Institute) within 24 hours prior to Day 1. 6. Symptomatic primary or metastatic
- •CNS malignancy. 7. Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active
- •infection or any uncontrolled medical condition (other than malignancy) that, in the opinion of the investigator, may confound the results of the
- •study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting, CINV) or pose
- •unwarranted risks in administering the study drugs to the patient. 8. Known hypersensitivity or contraindication to 5-HT3 receptor
- •antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron,tropisetron, ramosetron) or dexamethasone. 9. Previously received an
- •NK1 receptor antagonist (e.g., aprepitant, casopitant). 10. Participation in a clinical trial involving oral netupitant administered in combination with palonosetron. 11. Any investigational drugs taken within 4 weeks
- •prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study.Exclusion Criteria (Multiple-Cycle Extension):The following exclusion criteria must be checked prior inclusion at each cycle of the Multiple-Cycle Extension: 1. If female, pregnant or lactating, i.e. positive urine dipstick pregnancy test within 24 hours prior to Day 1.
- •2. Active infection or uncontrolled disease except for malignancy. 3.Started any of the restricted medications. 4. Any vomiting, retching, or mild nausea (grade greater or equal than I as defined by National Cancer
- •Institute) within 24 hours prior to Day 1.
研究者
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