Health Condition 1: C00-D49- Neoplasms Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 3: C15-C26- Malignant neoplasms of digestive organs Health Condition 4: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs Health Condition 5: C50-C50- Malignant neoplasms of breast Health Condition 6: C60-C63- Malignant neoplasms of male genital organs Health Condition 7: C51-C58- Malignant neoplasms of female genital organs Health Condition
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.In patients with Histologically/cytologically confirmed solid malignancies. 2.Patients with ECOG performance status 0-2. 3.Patients scheduled for Gemcitabine based chemotherapy (monotherapy or in combination). 4.Signed, written informed consent 5.Adequate organ function(as per standard laboratory values)
Exclusion criteria
Exclusion criteria: 1.History of hematologic malignancy from bone marrow aspirate and biopsy or peripheral blood test in the prior 3 months. 2.Patients with pre-existing platelet count less than 1,00,000 cells/microL. 3.Patients with Active bleeding or coagulopathy. 4.Prior use of TPO receptor agonists 5.Patients with uncontrolled infection or uncontrolled Type 2 Diabetes Mellitus, Systemic Hypertension, chronic Diseases/ illness. 6.Pregnant women and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To asses whether prophylactic use of Tablet Eltromobopag in different doses reduce the degree and duration of Gemcitabine based chemotherapy induced thrombocytopenia Timepoint: After 4 consecutive cycles of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess whether the Tablet Eltrombopag is safe and adverse effect profile.Timepoint: After every cycle for 4 consecutive cycles | — |
Countries
India
Contacts
Stanley Medical College and hospital,Chennai