The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: BB 1101; Cisplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Emetics; Granisetron; Palonosetron

Criteria

Inclusion Criteria:

• Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol;

• The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration;

• Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy;

• Life expectancy ≥ 3 months;

• Adequate hematologic function;

• Adequate hepatic function;

• Adequate renal function;

• At least 2 weeks away from the last chemotherapy;

• Patients signed written informed consent.

Exclusion Criteria:

• Pregnant or lactating women;

• History of anticipatory vomiting;

• Radiation therapy on the abdomen or pelvis within one week prior to study entry;

• Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.);

• Patients with gastrointestinal obstruction;

• Patients with severe heart disease, liver or renal disease, or metabolism disorders;

• Patients with epilepsy or using sedative or psychotropic drugs;

• Patients with diabetes or with contraindication for corticosteroids;

• Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry;

• Patients with brain metastasis or intracranial hypertension;

• Hypersensitivity to 5-HT3 receptor antagonist;

• Patients with active infection;

• Other conditions that the investigator considered as unsuitable for chemotherapy;

• Subjects participating in other clinical trials.