Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Aprepitant; Casopitant; Dexamethasone; Fosaprepitant; Ondansetron

Criteria

Inclusion criteria:

• Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.

• Diagnosed with a solid malignant tumour and has not previously received chemotherapy.

• Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.

Exclusion criteria:

• Not received any investigational product within 30 days of enrolment into the study.

• Must not be pregnant.

• Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.

• Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.

• Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).

• Must not have a history of peptic ulcer disease.