Overview
An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Xijing HospitalTreatments:
Granisetron
Palonosetron
Criteria
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