study to observe effect of aprepitant for prevention of nausea and vomiting
- Conditions
- Health Condition 1: null- histologically confirmed malignancies on HEC/MEC regime
- Registration Number
- CTRI/2013/05/003629
- Lead Sponsor
- Glenmark Pharmaceuticals ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1000
•Male and female subjectâ??s >= 18 years of age.
•Patients with either MEC or HEC regimens
•Patients with histologically confirmed malignancies
•Karnofsky scores >= 60
•Predicted life expectancy >= 4 months
•Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed
•Patients with symptomatic primary or metastatic central nervous system malignancy
•Patients who had received or were to receive radiation therapy to the abdomen or pelvis in the week prior to treatment
•Patients who had vomited in the 24 hr prior to treatment
•Patients who had an active infection or any uncontrolled disease other than malignancy
Abnormal laboratory values (absolute neutrophil count 1,500/mm3, white blood cell count 3,000/mm3, platelet count 100,000/mm3, aspartate transaminase 2.5Ã? upper limit of normal, alanine transaminase 2.5Ã? upper limit of normal, bilirubin 1.5Ã? upper limit of normal, creatinine 1.5Ã? upper limit of normal).
•Patients taking systemic steroid therapy at any dose
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of patients reporting no vomitingTimepoint: 5 days following initiation of chemotherapy
- Secondary Outcome Measures
Name Time Method overall complete response (no emetic episodes and no administration of rescue therapy)Timepoint: 5 days (120 h) following the initiation of chemotherapy.