Phase 2
Completed
- Conditions
- Chemotherapy-induced nausea and vomiting
- Registration Number
- JPRN-jRCT2080223300
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
FosNTP 235 mg group showed superior prevention of chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based chemotherapy compared with the placebo group, and with a satisfactory safety profile.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 594
Inclusion Criteria
Patients who are scheduled to receive cancer chemotherapy including the HEC agents
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1
- Patients who have provided written informed consent
Exclusion Criteria
- Patients with infection, diabetes mellitus, or other disease to whom it difficult to administer of DEX, which is defined in the protocol
- Patients who are unable or unwilling to cooperate in the implementation of study procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>CR rate during the first 120 hours after the start of administration of an HEC
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>- Efficacy<br>- Safety<br>- Pharmacokinetics