EUCTR2015-001800-74-CZ进行中（未招募）1 期
A phase 3, multicenter, randomized, double-blind, active control study to evaluate the safety and efficacy of IV pro-netupitant/palonosetron (260 mg/0.25 mg) combination for the prevention of chemotherapy-induced nausea and vomiting in repeated chemotherapy cycles in patients receiving highly emetogenic chemotherapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The following inclusion criteria must be checked prior to inclusion at Cycle 1:
- •1. Signed written informed consent.
- •2. Male or female patient = 18 years of age.
- •3. Histologically or cytologically confirmed solid tumor malignancy.
- •4. Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.
- •5. Scheduled to receive at least 4 repeated consecutive cycles of the following highly emetogenic reference chemotherapies (HEC), alone or in combination with other chemotherapeutic agents* on Day 1:
- •- cisplatin administered as a single IV dose of = 70 mg/m2
- •- cyclophosphamide = 1500 mg/m2
- •- carmustine (BCNU) >250mg/m2
- •- dacarbazine (DTIC)
- •- mechloretamine (nitrogen mustard)
- •* on Day 1, additional chemotherapeutic agents have to be administered after the start of the reference chemotherapy administration and their administration must be completed no more than 6 hours after the start of reference chemotherapy infusion. Low, minimally or not emetogenic chemotherapies can be administered at any time from Day 2 onwards.
- •6. ECOG Performance Status of 0, 1, or 2
- •7. If a patient is female, she shall be:
- •a) of non-childbearing potential or
- •b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test.
- •8. Hematologic and metabolic status adequate for receiving a HEC regimen and fulfillment of the following criteria:
- •a. Total Neutrophils = 1500/mm3 (Standard units: = 1.5 x 10^9/L)
- •b. Platelets = 100,000/mm3 (Standard units: = 100.0 x 10^9/L)
- •c. Bilirubin = 1.5 x Upper Limit of Normal (ULN)
- •d. Liver enzymes:
- •ii. Without known liver metastases, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) iii. With known liver metastases, AST and ALT e. Serum Creatinine 9. Able to read, understand, follow the study procedure and complete patient diary.
- •Cycles 2 to 4:
- •The following inclusion criteria must be checked prior to inclusion at each repeated cycle:
- •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. Scheduled to receive the same chemotherapy regimen as Cycle 1 or one of the reference chemotherapies as defined in Inclusion criterion # 5 for Cycle 1.
- •3. If a patient is female, she shall be:
- •a) of non-childbearing potential or
- •b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test.
- •4. Adequate hematologic and metabolic status according to the Investigator’s opinion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •to be checked prior to inclusion at Cycle 1:
- •1. Lactating woman.
- •2. Active infection or uncontrolled disease except for malignancy that may pose unwarranted risks in administering the study drugs to the patient.
- •3. Current use of illicit drugs or current evidence of alcohol abuse.
- •4. Scheduled to receive moderately or highly emetogenic chemotherapies from Day 2 to Day 5.
- •5. Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of the reference chemotherapy administration on Day 1 or between Days 1 to 5.
- •6. Any vomiting, retching, or nausea (grade = 1 as defined by National Cancer Institute) within 24 hours prior to the start of the reference chemotherapy administration on Day 1.
- •7. Symptomatic primary or metastatic CNS malignancy.
- •8. Known hypersensitivity or contraindication to 5-HT3 receptor antagonists to dexamethasone or to NK-1 receptor antagonists.
- •9. Known contraindication to the IV administration of 50 mL 5% glucose solution.
- •10 . Previously received an NK-1 receptor antagonist.
- •11. Participation in a previous clinical trial involving IV pro-netupitant or oral netupitant administered alone or in combination with palonosetron.
- •12. Any investigational drugs (other than those given in this study) taken within 4 weeks prior to Day 1, and/or is scheduled to receive any investigational drug during the present study.
- •13. Systemic corticosteroid therapy at any dose within 72 hours prior to the start of reference chemotherapy administration on Day 1. However, topical and inhaled corticosteroids are permitted.
- •14. Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.
- •15. Scheduled to receive any strong or moderate inhibitor of CYP3A4 or its intake within 1 week prior to Day 1
- •16. Scheduled to receive any of the following CYP3A4 substrates within 1 week prior to Day 1: terfenadine, cisapride, astemizole, pimozide.
- •17. Received within 4 weeks prior to Day 1 or scheduled to receive any CYP3A4 inducer
- •18. Any medication with known or potential antiemetic activity within 24 hours prior to the start of reference chemotherapy administration on Day 1 of Cycle 1, including:
- •a. 5-HT3 receptor antagonists
- •b. NK-1 receptor antagonists
- •c. benzamides
- •d. phenothiazines
- •e. benzodiazepines (except if the patient is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to Day 1)
- •f. butyrophenones
- •g. anticholinergics
- •h. antihistamines
- •i. domperidone
- •j. mirtazapine
- •k. olanzapine
- •l. prescribed cannabinoides
- •m. Over The Counter (OTC) antiemetics, OTC cold or OTC allergy medications.
- •19. History or predisposition to cardiac conduction abnormalities, except for incomplete right bundle branch block.
- •20. History of Torsade de Point or known history of risk factors for Torsade de Point
- •21. Severe cardiovascular diseases diagnosed within 3 months prior to Day 1 of first cycle, including myocardial infarction, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) NYHA class III-IV, and severe uncontrolled arterial hypertension.
- •22. Any illness or condition that, in the opinion of the Investigator, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient.
- •23. Concurrent medical condition that would preclude administra
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