Health Condition 1: null- histologically confirmed malignancies on HEC/MEC regime
Conditions
Interventions
Intervention1: Aprepitant: 125mg and 80 mg. 125 mg is administered 1 hour prior to initiating chemotherapy treatment (day 1) and 80mg once daily on days 2 and 3.
Control Intervention1: not applicabl
Sponsors
Glenmark Pharmaceuticals ltd
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of patients reporting no vomitingTimepoint: 5 days following initiation of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| overall complete response (no emetic episodes and no administration of rescue therapy)Timepoint: 5 days (120 h) following the initiation of chemotherapy. | — |
Countries
India
Contacts
Public ContactDrChetan Deshmukh
Deshmukh Clinic
Outcome results
None listed