Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Palonosetron and Olanzapine without dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hee Jun Kim
• Collaborators: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Olanzapine; Palonosetron

Criteria

Inclusion Criteria:

• European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

• no severe cognitive compromise

• Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st cycle

• Confirmed histology

Exclusion Criteria:

• European Cooperative Oncology Group (ECOG) performance status of 3 and 4

• Nausea or vomiting in the 24 hours before enrollment

• History of Nausea or vomiting Grade 3 before previous chemotherapy

• Known history of central nervous system disease (e.g., brain metastases or a seizure disorder)

• Bowel obstruction

• Serum creatinine level of 2.0 mg per deciliter (177 μmol per liter) or more

• Aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range

• Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment

• Treatment with another antiemetic agent before 48 hours before enrollment

• Uncontrolled severe infection or uncontrolled severe comorbidity

• Concurrent abdominal radiotherapy

• Known hypersensitivity to olanzapine, palonosetron

• Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 month