Clinical trial · Interventional
An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients
A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients
NCT00666783CI-TRIAL-00001428completedPhase 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 clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.
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 |
|---|---|---|---|
| Chemotherapy-Induced Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granisetron | Drug | — | UNRESOLVED |
| palonosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PAL
- description
- receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2)
- interventionNames
- Drug: palonosetron
- type
- ACTIVE_COMPARATOR
- label
- GRA
- description
- receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2)
- interventionNames
- Drug: Granisetron
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female, age ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease * naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one * Karnofsky index more than 70% and anticipated survival time more than 90 days * Scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the chemotherapy should be accomplished on study Day 1 * No emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration * Adequate organ functions(No impairment to renal, hepatic, cardiac or bone marrow function ) * Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit * Provision of written informed consent Exclusion Criteria: * Inability to understand or cooperate with study procedures * Receipt of investigational drugs 30 days before study entry * Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment * Contraindications to 5-HT3 receptor antagonists * Woman Patient with Pregnancy or lactation * Diagnosed with hypertension or severe infectious diseases * Obstructive symptom of gastrointestinal tract * Symptomatic brain metastasis or mental dysfunction * Baseline QTc \> 500 ms
References
Publications (0)
Data not yet available
No reference posted for this study.