Trial | NCT00503386  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    144
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.
Study Started
Apr 30
2006
Primary Completion
Oct 31
2006
Study Completion
Oct 31
2006
Last Update
Sep 17
2010
Estimate

Drug Palonosetron

Drug Granisetron

Criteria 

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
No Results Posted