EUCTR2013-002763-25-IT进行中（未招募）不适用
A randomised, double-blind, placebo-controlled study to evaluate the efficacy of two different dose levels of orvepitant (10 and 30 mg) compared with placebo on EGFRi-induced intense pruritus in oncology subjects(The RELIEVE 1” Study) - RELIEVE 1
eRRe Therapeutics Ltd0 个研究点开始时间: 2013年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Male and female subjects > 18 years of age
- •Subjects with a diagnosis of malignant solid tumours and undergoing treatment with one of the following EGFRi medicines [cetuximab (Erbitux®), panitumumab (Vectibix®), erlotinib (Tarceva®), lapatanib (Tyverb®), gefitinib (Iressa®]. Subjects expected treatment duration with their EGFRi must exceed the study duration
- •Subjects experiencing intense pruritus symptoms following treatment with one of the following EGFRi medicines [cetuximab (Erbitux®), panitumumab (Vectibix®), erlotinib (Tarceva®), lapatanib (Tyverb®), Gefitinib (Iressa®]. Intense pruritus symptoms are defined by subjects reporting a clinic visit NRS score = 7, (where 0 = No Itch and 10 = Worst Itch Imaginable) at the Screening visit, confirmed again at Baseline visit:
- •Willing to refrain from all non-permitted concomitant medication from the Screening visit through to the Week 8 visit
- •Willing to refrain from all insomnia medication for the duration of the study
- •ECOG performance status of 0 to 2
- •Life expectancy of > 6 months in the opinion of the Investigator
- •Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study. A female is considered of childbearing potential unless she is:
- •opostmenopausal for at least 12 months prior to study drug administration;
- •owithout a uterus and/or both ovaries; or
- •oHas been surgically sterile for at least 6 months prior to study drug administration.
- •Reliable methods of contraception are:
- •oHormonal methods or intrauterine device in use > 90 days prior to study drug administration;
- •oBarrier methods plus spermicide in use at least 14 days prior to study drug administration; or
- •oVasectomized partner
- •Female subjects of childbearing potential who are not sexually active may not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they commit to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study
- •Able to understand and comply with the requirements of the study and sign the Informed Consent Form
- •Laboratory values (Haematology, Biochemistry and Urinalysis values) will be appropriate for subjects with cancer diagnosis, under treatment with EGFRis and dependent on the Investigator’s clinical judgement, where the ranges are not specified below:
- •oHaematology:
- •?Haemoglobin
- •?Haematocrit
- •?Red blood cell (RBC), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH), Mean Corpuscular Haemoglobin Concentration (MCHC)
- •?White blood cell (WBC) count and differential
- •?Neutrophils = 1,500 /dL
- •?Platelets = 100,000 /dL
- •oBiochemistry:
- •?Serum creatinine = 1.5 mg/dL
- •?Total bilirubin < 2.0 mg/dL
- •?Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) = 2.5 x upper limit of normal (ULN)
- •?Uric acid, total protein, albumin, gamma glutamyl transpeptidase (gamma GT), glucose, phosphorous, potassium, sodium, calcium, and chloride
- •oUrinalysis:
- •?Dipstick test: protein, blood, ketones, glucose; microscopy will be done on urine samples if the result of the dipstick test for protein or blood is abnormal, but dependent on the site of the subject’s cancer (to be reviewed as n
排除标准
- •Treatment for any other type of pruritus within the previous 3 months (e.g. pruritus in atopic eczema or non-EGFRi-related skin diseases, nephrogenic pruritus, cholestatic pruritus)
- •Prior use of aprepitant (Emend®) or fosaprepitant (Ivemend®), NK-1 antagonists licensed as antiemetics in cancer therapy within 4 weeks of the Screening visit
- •History of hypersensitivity or idiosyncratic reaction to any excipients/components of the test medication
- •Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control (except those who are not sexually active)
- •Prior history of seizure or traumatic brain injury
- •Subjects with known or suspected brain tumour or metastases
- •Any current diagnosis or history of a clinically significant abnormality of the neurological system (including demyelinating disorders such as multiple sclerosis, peripheral neuropathic demyelinating or axonal disorders, dementia and other cognitive disorders or significant head injury)
- •Any moderate to severe acute illness which in the opinion of the Investigator would interfere with the study procedures or study outcome
- •History of unstable cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant by the Investigator, but consistent with diagnosis of solid tumours
- •History of poor co-operation, non-compliance with medical treatment, or unreliability
- •Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to consenting to study entry
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