Clinical trial · Interventional
A Randomized Study of Olanzapine for the Prevention of CINV in Patients Receiving Moderately Emetogenic Chemotherapy
NCT02400866CI-TRIAL-00017294unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy by a randomized, double-blind, placebo-controlled trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olanzapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- palonosetron + dexamethasone + placebo
- type
- EXPERIMENTAL
- label
- Experimental
- description
- palonosetron + dexamethasone + olanzapine
- interventionNames
- Drug: Olanzapine
Primary outcomes (1)
- measure
- complete response rate for the acute phase (0-24 hours) after chemotherapy
- timeFrame
- during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC)
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * over 19 years of age * no history of receiving moderately or highly emetogenic chemotherapy during last 6 months, and is to receive a first course of MEC including one or more of following agents: Carboplatin, Cyclophosphamide ≤ 1,500 mg/m2, Daunorubicin, Doxorubicin \< 60 mg/m2, Epirubicin ≤ 90 mg/m2, Irinotecan, Oxaliplatin, Melphalan, Methotrexate ≥ 250 mg/m2 * ECOG performance status 0-2 * predicted life expectancy ≥ 3 months * adequate bone marrow, kidney, and liver functionas evidenced by: ANC ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, total bilirubine ≤ 2 x ULN, AST ≤ 3 x ULN, ALT ≤ 3 x ULN (for subjects with known liver metastases, total bilirubin ≤ 3 x ULN, AST ≤ 5 x ULN, ALT ≤ 5 x ULN), Creatinine ≤ 1.5 x ULN or Ccr ≥ 50 ml/min * no episodes of nausea and vomiting during last 24 hours before enrollment * subjects provides written informed consent Exclusion criteria: * subjects with uncontrolled neuro-psychiatric disease (alcohol abuse, seizure, psychosis etc) except malignant tumor * subject is scheduled to receive highly emetogenic chemotherapeutic agents: Doxorubicin or Epirubicin + cyclophosphamide, Cisplatin ≥ 50 mg/m2, Carmustine \> 250 mg/m2, Cisplatin ≥ 50 mg/m2, Cyclophosphamide \> 1,500 mg/m2, Dacarbazine, Doxurubicine ≥ 60 mg/m2, Epirubicine \> 90 mg/m2, Ifosfamide ≥ 2 g/m2 per dose, Mechlorethamine, Streptozocin * contraindication to the administration of palonosetron, dexamethasone, and olanzapine due to hypersensitivity or any other reasons * subject has severe cognitive impairment * subjects has symptomatic or uncontrolled brain metastasis or brain tumor * female subjects of childbearing potential who dose not agree to use a proper contraceptive methods or to limit breast feeding * subject has taken the following agents: risperidone, quetiapine, clozapine, phenothiazine, butyrophenone, 5-HT3 antagonist, bezamides, domperidone, cannabinoids, NK1 antagonist, bezodiazepines * subject has a plan to receive other chemotherapy, abdomial radiation, surgery, or immunotherapy * any history of arrhythmia, uncontrolled congestive heart failure, acute myocardial infarction durting last 6 months * history of uncontrolled diabetes * subject who has used any investigational drugs within 30 days of randomization
References
Publications (0)
Data not yet available
No reference posted for this study.