A randomized, double blinded, parallel-group, phase 3 study to investigate the efficacy andtolerability of palonosetron, dexamethasone, aprepitant plus oral cannabinoid versuspalonosetron, dexamethasone and aprepitant alone in patients receiving highly emetogenicchemotherapeutic (HEC) regimens
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 644
- 试验地点
- 1
- 主要终点
- The primary endpoint of interest between the two arms of antiemetics is the complete response (CR) rates post 1st cycle of chemotherapy. This is the basis for statistical considerations as men-tioned above.
研究概览
简要总结
Study rationale Chemotherapy induced nausea and vomiting (CINV) are unpleasant and worrisome side effects associated with the administration of chemotherapy. Improved control of emesis positively ,impacts quality of life in patients receiving chemotherapy. Current antiemetic regimens have markedly reduced the incidences of nausea and vomiting across chemotherapy regimens, though breakthrough CINV rates range between 10-30% across regimens.
Primary
Objectives: The primary objective is to compare an antiemetic regimen consisting of aprepitant, palonosetron, dexamethasone and oral THC/CBD (active arm) and a regimen consisting of aprepitant, palonosetron, dexamethasone, and placebo (control arm) with respect to complete response (CR); the proportion of subjects with no vomiting, no significant nausea (scored as < 5 on a scale of 1-100) and no use of rescue medications during pre-specified HEC protocols for 1 cycle of chemotherapy
Hypothesis: The addition of THC/CBD to palonosetron, dexamethasone and aprepitant combination will increase the CR rates [(the proportion of subjects with no vomiting, no significant nausea (scored as < 5 on a scale of 1-100) and no use of rescue medications] during HEC regimens.
Objectives
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To compare the THC/CBD containing regimen to the control arm with respect to no emesis rates (the proportion of subjects with no vomiting, and no use of rescue medications) during HEC protocols for 1 cycle of chemotherapy
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To compare the THC/CBD containing regimen to the control arm with respect to proportion of patients with no significant nausea (< 5 on a score of 1- 100) during pre-specified HEC protocols for 1 cycle of chemotherapy
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to compare quality of life using FLIE questionnaire
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To compare tolerance and side effects with both regimens
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients has a confirmed diagnosis of cancer and is receiving one of the mentioned chemo-therapy protocols mentioned previously.
- •The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
- •The patient is aged > 18 years.
- •a) Patients should be chemotherapy naive b)The patient has a WHO Performance Status of ≤ c)Hematologic and metabolic status must be adequate for receiving planned chemotherapy, and meet the following criteria: 3) Total neutrophils ≥ 1500/mm3 Platelets ≥ 100,000/mm3 Bilirubin ≤ 1.5 x ULN (Upper Limits of Normal)Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 x ULN GFR ≥ 50 ml/min 4)The patient is able to read, understand, and complete questionnaires and daily compo-nents of the Patient Diary for each study cycle.
- •For patients of childbearing potential, urine human chorionic gonadotropin (hCG) (urine dipstick pregnancy test) or blood hCG results must be negative at screening.
- •Has a normal baseline ECG with QTc prolongation.
排除标准
- •The patient is unable to read, understand, and complete the forms required for the study.
- •The patient is pregnant (serum pregnancy test) or lactating.
- •The patient has experienced emesis (i.e., vomiting and/or retching) or clinically significant nausea (defined as nausea graded as moderate or severe) in the 24 hours preceding the first dose of study medication.
- •The patient has a history active peptic ulcer disease, significant or symptomatic, acute or subacute gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the patient.
- •The patient has a known hypersensitivity or contraindication to palonosetron, another 5-HT3 receptor antagonist, dexamethasone, aprepitant or THC/CBD 6) The patient has received an investigational drug in the previous 6 months or is scheduled to receive any investigational drug other than fosaprepitant dimeglumine during the study period 7) The patient has taken/received any medication of moderate or high emetogenic potential within the 48 hours prior to the first dose of study medications.
- •Opiate drugs for cancer pain will be permitted if the patient has been on a stable dose and has not experienced emesis or clinically significant nausea from the narcotics in the 24 hours preceding the first dose of study medication.
- •The patient has taken/received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drugs.
- •This is inclusive of, but not limited to 5 HT3 antagonists, metoclopramide, benzodiazepines, phenothiazines, haloperidol, oral or intravenous steroids, antihistamines, domperidone, olanzapine, antipsychotics 9) Has taken drugs which may influence medications used in the study, e.g. CYP inducers or inhibitors.
结局指标
主要结局
The primary endpoint of interest between the two arms of antiemetics is the complete response (CR) rates post 1st cycle of chemotherapy. This is the basis for statistical considerations as men-tioned above.
时间窗: 54 month
次要结局
- -‘No emesis rates’ between the 2 arms for cycle 1 individually(-No significant nausea rates between the 2 arms for cycle 1 individually)