Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503386

Enrollment

144

Registered

2007-07-18

Start date

2006-04-30

Completion date

2006-10-31

Last updated

2010-09-17

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

Conditions

Chemotherapy, Nausea, Vomiting

Keywords

chemotherapy-induced nausea and vomiting, acute, delayed, emesis, antiemetics, 5-HT3 receptor antagonist, granisetron, palonosetron

Brief summary

The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.

Interventions

DRUGPalonosetron

DRUGGranisetron

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Male or female, age ≥ 18 yrs and \<70 yrs with histologically or cytologically confirmed * Malignant disease * Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60 * Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 \ 80 mg/m2 on study Day 1 * Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit * Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion * Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion * Predicted life expectancy of ≥ 3 months * Provision of written informed consent.

Exclusion criteria

* Inability to understand or cooperate with study procedures * Receipt of investigational drugs ≤ 30 days before study entry * Receipt of other investigational drugs during the course of this study * Seizure disorder or any condition requiring anticonvulsants, sedatives * CNS malignancy or metastasis * Ongoing emesis due to obstruction of digestive tract * Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy * Moderate or severe nausea and vomiting after any previous chemotherapy * Scheduled receipt of any chemotherapeutic agent with an emetogenicity level \>3 during study Days 2-5 * Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5 * Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5 * Contraindications to 5-HT3 receptor antagonists * Contraindications to chemotherapy

Design outcomes

Primary

Measure	Time frame
Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)	0-24h, 24-120h , 0-120h following chemotherapy

Secondary

Measure	Time frame
Major Protection from vomiting	0-24h,24-120h,0-120h following chemotherapy
Major Protection from nausea	0-24h,24-120h,0-120h following chemotherapy
Complete Protection from Both Vomiting and Nausea	0-24h,24-120h,0-120h following chemotherapy
Complete Protection from Both Vomiting and Moderate-to-Severe nausea	0-24h,24-120h,0-120h following chemotherapy
Time to First Emetic Episode	0-120h following chemotherapy

Countries

China

Outcome results

None listed

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