Phase 2 study of efficacy and safety of fosaprepitant in patients with solid tumor receiving highly emetogenic chemotherapy
Phase 2
- Conditions
- Patients with solid tumor receiving highly emetogenic chemotherapy including cisplatin.
- Registration Number
- JPRN-UMIN000012202
- Lead Sponsor
- Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) patients who have need of administration of aprepitant over 4 days 2) with allergy to aprepitant 3) Possibly pregnant, or breast feeding woman 4) with Acute myocardial infaction in 6 months or with unstable ungina, congestive heart failure (NYHA >= class3), other serious cardiac disoder 5) patients with symptomatic brain metastasis 6) with hypercalcemia requiring an urgent treatment 7) patients taking medicines interacted with CYP3A4 or CYP2C9 8) with uncontrolled diabetes mellitus 9) with pleural effusion, ascitis and pericardial effusion 10) patients who are disqualified by attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate (defined as no emesis and no rescue treatment) in overall phase(0-120hr after chemotherapy).
- Secondary Outcome Measures
Name Time Method 1) Complete response rate in acute (0-24hr after chemotherapy) and delayed (24-120hr after chemotherapy) phases. 2) Complete control rate (defined as no nausea and no emesis and no rescue treatment) in overall, acute and delayed phases. 3) ratio of patients without nausea in overall, acute and delayed phases. 4) adverse events in 14 days after chemotherapy. 5) evaluation of volume of meal intake in acute and delayed phases.