CTRI/2012/01/002343尚未招募3 期
A phase III, multicenter, randomized, double-blind, unbalanced (3:1) active control studyto assess the safety and describe the efficacy of netupitant and palonosetron for theprevention of chemotherapy-induced nausea and vomiting in repeated chemotherapycycles.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 400
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 18 years of age.
- •3. Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
- •4. Diagnosed with a malignant tumor.
- •5. If scheduled to receive repeated consecutive courses of chemotherapy, a single dose of one or more of the following agents administered on Day 1 is allowed:
- •- Highly emetogenic chemotherapy (HEC): any I.V. dose of cisplatin, mechlorethamine, streptozocin, cyclophosphamide 1500 mg/m2, carmustine, dacarbazine;
- •- Moderately emetogenic chemotherapy (MEC): any I.V. dose of oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin, cyclophosphamide I.V. ( < 1500 mg/m2), cytarabine I.V. ( > 1 g/m2), azacidine, alemtuzumab, bendamustine, or clofarabine.
- •6. If scheduled to receive combination regimens, the most emetogenic agent according
- •to the MASCC/ESMO Antiemetic Guidelines 2010 is to be given as first on Day 1 and the infusion must be completed within 6 hours.
- •7. If scheduled to receive chemotherapy agents of minimal to low emetogenic potential (Appendix 4), they are to be given on Day 1 following the most emetogenic agent or on any subsequent study day.
- •8. ECOG Performance Status of 0, 1, or 2 (Appendix 5).
- •9. 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. In addition, postmenopausal definition has to be confirmed
- •by consistent age and/or Follicle-Stimulating Hormone (FSH) levels)
排除标准
- •1. If female, lactating or pregnant i.e. positive urine dipstick pregnancy test within 24 hours prior to Day 1 of each cycle.
- •2. Current use of illicit drugs or current evidence of alcohol abuse.
- •3. Scheduled to receive either:
- •a) cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. doxorubicin (40 mg/m2)
- •b) cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. epirubicin (60 mg/m2).
- •4. Scheduled to receive moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) from Day 2 to Day 5 following Day 1 chemotherapy administration.
- •5. Active infection or uncontrolled disease except for malignancy that may pose unwarranted risks in administering the study drugs to the patient.
- •6. Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone.
- •7. Previously received an NK1 receptor antagonist (e.g., aprepitant, casopitant).
- •8. Participation in a clinical trial involving oral netupitant administered in combination with palonosetron.
- •9. 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.
- •10. Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1 of cycle 1. However topical and inhaled corticosteroids with a steroid dose of £ 10 mg of prednisone daily or its equivalent are permitted. Non-study drug dexamethasone as pre-medication in patients scheduled to receive taxanes is allowed.
研究者
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