Clinical trial · Interventional
Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)
Study to Evaluate the Efficacy and Safety of Single IV Doses of Onicit® (Palonosetron) 0.25 mg in the Prevention of Acute and Delayed Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in Colombia
NCT00684463CI-TRIAL-00027594completedPhase 4ClinicalTrials.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)
The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palonosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Palonosetron
- description
- 0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent
- interventionNames
- Drug: Palonosetron
Primary outcomes (1)
- measure
- Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.
- timeFrame
- During 24 hours after administration of chemotherapy.
Secondary outcomes (3)
- measure
- Proportion of patients who achieved a CR and of those who achieved complete control
- timeFrame
- Days 1 to 5 at different time intervals for each secondary outcome.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be 18 years of age or older. * Histological or cytological confirmation of malignant disease. * Karnofsky index \>= 50% * Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3). * Patients that voluntarily sign the consent form. Exclusion Criteria: * Pregnancy or suspected. * Patients during breast feeding. * Inability to understand or cooperate with the study procedures. * Received any investigational drugs within 30 days before study entry. * Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment * Seizure disorders requiring anticonvulsant medication. * Persistent vomiting due to any organic etiology. * Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy. * Any systemic disease different to base disease * Known current or history of drug or alcohol abuse * Gastric outlet or intestinal obstruction
References
Publications (0)
Data not yet available
No reference posted for this study.