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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00666783

Enrollment

208

Registered

2008-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2008-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-Induced Nausea and Vomiting

Brief summary

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.

Interventions

DRUGpalonosetron

receive a single, intravenous dose of palonosetron 0.25 mg, 30 minutes before receiving highly emetogenic chemotherapy.

DRUGGranisetron

receive a single, intravenous dose of granisetron 3 mg, 30 minutes before chemotherapy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026