JPRN-UMIN000024676
Completed
Phase 3
A randomized, double-blind, placebo-controlled phase III trial evaluating olanzapine 5mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: J-SUPPORT 1604 - J-FORCE STUDY: J-SUPPORT and the Fourth agent Olanzapine Resist Cisplatin Emetogenesity.
AMED (Japan Agency for Medical Research and Development)0 sites690 target enrollmentNovember 1, 2016
ConditionsMalignant solid tumor
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Malignant solid tumor
- Sponsor
- AMED (Japan Agency for Medical Research and Development)
- Enrollment
- 690
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\. History of hypersensitivity or allergy for study drugs or similar compounds. 2\. Patients who need antiemetics at the enrollment. 3\. Patients who start taking opioids within 48 hours prior to enrollment. 4\. Patient who suffered from ischemic heart disease, cerebral hemorrhage or apoplexy, active gastric or duodenum ulcer within 6 months prior to enrollment. 5\. Patients who has a convulsive disorders that need anticonvulsants therapy. 6\. Patients with symptomatic ascites that need therapeutic drainage. 7\. Patients with gastro\-intestinal stenosis or obstruction. 8\. Pregnant, breastfeeding or expecting woman. 9\. Psychotic patients using antipsychotic drug. 10\. Patient who received abdominal or pelvic irradiation within 6 days prior to enrollment or patients who receive abdominal or pelvic concurrent chemoradiotherapy. 11\. Patients who had diabetes mellitus with use of antidiabetics and patients with HbA1c (NGSP) \>\= 6\.5 or HbA1c (JDS) \>\= 6\.1\. 12\. Patients who cannot be hospitalized during 6 days (0\-120 h post\-cisplatin administration). 13\. Habitual smoker at the enrollment. 14\. Patients judged by the investigator to be inappropriate for this study.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A study to test whether pazopanib can prevent or delay kidney tumor coming back after the tumor has been removedEUCTR2010-020965-26-SKovartis Pharma Services AG1,500
Active, not recruiting
Phase 1
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib - BAY73-4506 Phase III GIST 3rd/4th lineEUCTR2009-017957-37-FRBayer HealthCare AG170
Active, not recruiting
Phase 1
Study of Reparixin combined with paclitacel compared to paclitaxel alone in patients with metastatic Triple-negative breast cancerEUCTR2014-004796-23-PLDompé Farmaceutici s.p.a.123
Active, not recruiting
Phase 1
16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsEUCTR2013-001090-24-BEovartis Pharma Services AG222
Active, not recruiting
Phase 1
A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISEEUCTR2006-000470-78-FRGlaxoSmithKline Research and Development Limited