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Antiemetic
olanzapine plus fosaprepitant-based triple regimen for Solid Tumor Patients Receiving Multi-day Chemotherapy (OFFER Trial)
Phase 3
Waitlist Available
Research Sponsored by Sun Yat-sen University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 8 after highly emetogenic chemotherapy initiation
Awards & highlights
Summary
This is a multicenter, randomized, controlled, double-blind, phase III study.
Eligible Conditions
- Solid Tumor Patients Receiving Multi-day Chemotherapy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 8 after highly emetogenic chemotherapy initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 8 after highly emetogenic chemotherapy initiation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete response (CR) during overall phase
Secondary study objectives
To compare the change of score using Hospital Anxiety and Depression Scale
Other study objectives
The plasma concentration of 5-hydroxytryptamine and substance P at the baseline
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: olanzapine plus fosaprepitant-based triple regimenExperimental Treatment1 Intervention
Olanzapine(5mg p.o. d1-d5)plus fosaprepitant(150mg i.v. d1-d3) plus ondansetron(8mg i.v. d1-d3)and dexamethasone(6mg p.o. d1-d5) before undergoing chemotherapy.
Group II: Placebo plus fosaprepitant-based triple regimenPlacebo Group1 Intervention
Placebo plus fosaprepitant(150mg i.v. d1-d3) plus ondansetron(8mg i.v. d1-d3)and dexamethasone(6mg p.o. d1-d5) before undergoing chemotherapy.
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Who is running the clinical trial?
Sun Yat-sen UniversityLead Sponsor
1,577 Previous Clinical Trials
3,487,161 Total Patients Enrolled
Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry Sponsor
100 Previous Clinical Trials
19,911 Total Patients Enrolled
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