Methods |
Randomised, phase 2, parallel‐assignment study Study start date: February 2005 Study completion date: not provided
Masking: double‐blind Baseline patient characteristics: n.r. |
Participants |
Inclusion criteria
willing to provide written informed consent before receiving any study‐specific procedures or assessments
diagnosed solid malignant tumour
has not previously received chemotherapy
scheduled to receive chemotherapy conducive to regimens outlined in the study protocol
Exclusion criteria
has not received any investigational product within 30 days of enrolment into the study
must not be pregnant
must not be of child‐bearing potential or willing to use specific barrier methods outlined in the protocol
must not be scheduled to receive radiation therapy to abdomen or pelvis within seven (7) days before the start of study medication
must not be currently under treatment for a condition that may cause nausea or vomiting (e.g. active peptic ulcer disease, gastric obstruction)
must not have a history of peptic ulcer disease
Mean/median age, years: n.r. Gender: male + female Tumour/cancer type: solid malignancy Chemotherapy regimen: n.r. Country: Argentina, Austria, Belgium, Chile, Croatia, Czech Republic, Hong Kong, Hungary, Italy, Mexico, Netherlands, Pakistan, Peru, Philippines, Poland, Romania, Singapore, Slovakia, Taiwan |
Interventions |
Drug: aprepitant, ondansetron, GW679769, dexamethasone Study arms: not provided |
Outcomes |
Primary outcome
Secondary outcomes
routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, adverse events reporting
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Notes |
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