SPADE (Single nucleotide polymorphism associated with Palonosetron, Aprepitant and DExamethasone) study
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000010423
- Lead Sponsor
- aboratory of clinical pharmacology, Faculty of Pharmaceutical Sciences, Suzuka University of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 100
Not provided
1)Patients with some factors such as brain tumor, brain metastasis causing nausea and vomiting. 2)Received a CYP3A4 inducer (such as phenobarbital, phenytoin, carbamazepine, rifampicin and efavirenz) or inhibitor (such as clarithromycin, erythromycin, voriconazole, itraconazole and ritonavir) within 7 days before administration of anticancer drug. 3)Received a CYP2D6 inhibitor (terbinafine, fluvoxamine, paroxetine, escitalopram, duloxetine, cimetidine, quinidine) within 7 days before administration of anticancer drug. 4)Received a 5-HT3 receptor antagonist, D2 blocker or NK1 receptor antagonist within 7 days before administration of anticancer drug. 5)Received a radiation therapy within 14 days before administration of anticancer drug. 6)Hypersensitivity to therapeutic agent. 7)Patients who had been treated with one moderate of high emetogenic antitumour drug according to the 2012 National Comprehensive Cancer Network Clinical Practice Guidelines. 8)Pregnant 9)Unstable glycemic control. 10)Patients judged ineligible by researcher.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with complete response (defined as "no-emesis", and "no-rescue medication") in the overall phase (0-120 h after chemotherapy)
- Secondary Outcome Measures
Name Time Method