Skip to content

Effect of Tablet Eltrombopag to prevent Decrease in the Platelet count in Patients with Solid Cancers receiving Gemcitabine based Cancer Treatment.

A Comparative Study on Prophylactic use of Tablet Eltrombopag in varying doses to prevent Thrombocytopenia in Patients with Solid Tumour Malignancies receiving Gemcitabine based Chemotherapy : A Three armed, Prospective, Interventional Study. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094447
Enrollment
99
Registered
2025-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Tablet Eltrombopag: Tablet Eltrombopag 25 mg ,Tablet Eltrombopag 50 mg Intervention2: Tablet Eltrombopag 50mg: Patients diagnosed with solid malignancies who are receiving Gemcitabine b

Sponsors

Dr Chilamkurty Maitreyi
Lead Sponsor

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

MeasureTime 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

MeasureTime frame
To assess whether the Tablet Eltrombopag is safe and adverse effect profile.Timepoint: After every cycle for 4 consecutive cycles

Countries

India

Contacts

Public ContactDr P N Sathiyamoorthy

Stanley Medical College and hospital,Chennai

sathiyamoorthypn@gmail.com9444221535

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026