EUCTR2010-022742-25-ES进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rolapitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Tesaro, Inc.
- 入组人数
- 526
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
入选标准
- •1. Subject is 18 years of age or older, of either gender, and of any race.
- •2. Subject has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (?60 mg/m2).
- •3. Subject has a Karnofsky performance score of ?60.
- •4. Subject has a predicted life expectancy of ?4 months.
- •5. Subject has adequate bone marrow, kidney, and liver function as evidenced by:
- •a. Absolute neutrophil count ?1500/mm3.
- •b. Platelet count ?100,000/mm3.
- •c. Aspartate aminotransferase (AST)? 2.5 x upper limit of normal range (ULN). For subjects with known liver metastases ?5 x ULN.
- •d. Alanine aminotransferase (ALT)?2.5 x ULN. For subjects with known liver metastases ?5 x ULN.
- •e. Bilirubin ?1.5 x ULN, except for subjects with Gilbert?s syndrome.
- •f. Creatinine ?1.5 x ULN.
- •If a single or multiple laboratory test value exceeds, but is close to, the limit(s) of the reference range(s) as defined in the protocol inclusion criteria, subjects will be allowed to repeat these out-of-range tests once. If the repeated test results meet the study requirement, these subjects can be enrolled.
- •6. Female subjects of childbearing potential must agree to use a medically accepted method of birth control prior to Visit 1 and to continue its use during the study and for at least 30 days after the study. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, hormonal contraception, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), and surgical sterilization (e.g., vasectomy, hysterectomy, or tubal ligation). Female subjects who are postmenopausal (i.e., have amenorrhea for 12 months) or surgically sterile are exempted from the use of contraception during the study.
- •7. Subject is able to read, understand, and complete all study-related documents.
- •8. Subject provides written informed consent.
- •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 424
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 106
排除标准
- •1. Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject.
- •2. Subject has a contraindication to the administration of cisplatin, granisetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, or systemic infection.
- •3. Subject is a woman of childbearing potential with a positive urine or serum pregnancy test within 3 days prior to study drug administration or is breast feeding.
- •4. Subject has previously received cisplatin or subject is planning to receive multiple days of cisplatin in a single cycle
- •Subject has taken the following agents within the last 48 hours prior to the start of treatment with study drug.
- •a. 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.). Palonosetron is not permitted within 7 days prior to administration of investigational product.
- •b. Phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.).
- •c. Benzamides (metoclopramide, alizapride, etc.).
- •d. Domperidone.
- •e. Cannabinoids.
- •f. NK1 antagonist (aprepitant).
- •g. Benzodiazepines (lorazepam, alprazolam, etc.).
- •6. Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 4 or above (Hesketh Scale) from Day -2 through Day 6, except on Day 1. (There is no restriction for Day 1.)
- •7. Subject is scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6.
- •8. Subject has received systemic corticosteroids or sedative antihistamines (dimenhydrinate, diphenhydramine, etc.) within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes, pemetrexed). Subjects who are receiving inhaled steroids for respiratory conditions or topical steroids for skin disorders can be enrolled.
- •9. Subject has symptomatic primary or metastatic CNS disease.
- •10. Subject has ongoing vomiting, retching, clinically significant nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
- •11. Subject has vomited and/or has had dry heaves/retching within 24 hours prior to the start of cisplatin-based chemotherapy on Day 1 in Cycle 1.
- •12. Subject who has used any investigational drugs within 30 days of randomization.
- •13. Subject who is participating in any other clinical study.
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