Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15
研究概览
简要总结
This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the efficacy (i.e. change in nausea numeric rating scale [NRS] from baseline between day 5-15) of fixed dose netupitant and palonosetron hydrochloride (palonosetron) (NEPA) for chronic nausea in cancer patients.
SECONDARY OBJECTIVES:
I. To assess the secondary outcomes (e.g. proportion of patients who achieved their personalized nausea goal, antiemetic use, nausea episodes duration/frequency) for NEPA versus (vs.) placebo.
II. To assess the adverse effects associated with NEPA and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cancer
- •Chronic nausea over the past 4 weeks
- •Average nausea numeric rating scale >= 4/10 over the past 5 days at screening
- •Outpatient at MD Anderson Cancer Center
- •Karnofsky performance status >= 50%
- •Age 18 or older
- •Able to complete study assessments, including keeping a daily diary
排除标准
- •Delirium (i.e. Memorial Delirium Rating Scale > 13)
- •Clinical evidence of bowel obstruction at the time of study enrollment
- •Expected to use other 5HT3 antagonists or NK1 antagonists for prophylaxis during the study
- •Continuation of over-the-counter therapies for nausea and/or vomiting during the study
- •On cytotoxic chemotherapy in the high/moderate/low emetogenic risk categories or oral antineoplastic agents in the high or moderate emetogenic risk categories according to the latest National Comprehensive Cancer Network (NCCN) guideline within 2 weeks of study enrollment
- •On scheduled potent CYP3A4 inducers at the time of study enrollment (avasimibe, carbamazepine, phenytoin, rifampin, efavirenz, nevirapine, barbiturates, systemic glucocorticoids, modafinil, oxcarbazine, phenobarbital, pioglitazone, rifabutin, St. John's wort, troglitazone)
- •On scheduled CYP3A4 substrates with narrow safety range at the time of study enrollment (alfentanil, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus)
- •On scheduled strong or moderate CYP3A4 inhibitors (boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole; amprenavir, aprepitant, atazanavir, ciprofloxacin, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil) within one week of study enrollment
- •Unwilling to provide informed consent
- •Severe renal impairment (calculated creatinine clearance =< 29 cc/min)
- •Calculated creatinine clearance can be done within 14 days of study enrollment
- •Severe liver impairment (Child-Pugh score > 9)
- •Total (T.) bilirubin, albumin, prothrombin time, and serum creatinine tests can be done within 14 days of study enrollment (only if not performed in the last 14 days)
- •Females who are pregnant, lactating, or intend to become pregnant during the participation of the study; childbearing age women who are not on birth control; positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and no history of menses within the last 12 months; pregnancy test to be performed on the day of enrollment; in cases of women with elevated beta-human chorionic gonadotropin (b-HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy and the non-pregnant status is confirmed by a gynecologic examination
研究组 & 干预措施
Group I (netupitant, palonosetron hydrochloride)
Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.
干预措施: Netupitant (Drug)
Group I (netupitant, palonosetron hydrochloride)
Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.
干预措施: Palonosetron (Drug)
Group I (netupitant, palonosetron hydrochloride)
Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.
干预措施: Palonosetron Hydrochloride (Drug)
Group I (netupitant, palonosetron hydrochloride)
Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Group II (placebo)
Patients receive placebo PO on days 1, 6, and 11.
干预措施: Placebo (Other)
Group II (placebo)
Patients receive placebo PO on days 1, 6, and 11.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15
时间窗: Day 5 and Day 15
Average intensity of nausea over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10, where 0= none and 10= worse possible nausea. The total score ranged from 0-10. We measured the within-group change in nausea intensity from day 5 to day 15. Wilcoxon rank sum test was used for analysis.
次要结局
- Functional Living Index Emesis (FLIE): Nausea Sub-score(Baseline and Day 15)
- Functional Living Index Emesis (FLIE): Vomiting Sub-score(Baseline and Day 15)
- Index of Nausea, Vomiting and Retching: Total Experience Score(Day 5 and Day 15)