Health Condition 1: C49A- Gastrointestinal stromal tumor
Conditions
Interventions
Intervention1: Cabozantinib: Cabozantinib Dose- 60mg(subsequently reduced to 40mg and 20mg if drug toxicity occurs)
Route of Administration- oral
Frequency- Once daily
Duration of therapy- 3 months
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: a) Age 18-75 years b) Gastro-Intestinal Stromal tumor confirmed histologically. c) Metastatic/Unresectable disease, relapsed post 3 lines of therapy d) ECOG Performance status (PS) =2 e) Absolute Neutrophil Count >1000/mcl, Hemoglobin >8.0g/dL,Platelet > 1,00,000/mcL f) Normal renal function (Normal spot urine, Creatinine 30ml/min) g) Total bilirubin < 2.5x institutional ULN, ALT and AST <2.5 x ULN, alkaline phosphatase <2.5 xULN
Exclusion criteria
Exclusion criteria: a) Pregnant or breastfeeding patient b) Active or uncontrolled infection c) Locally recurrent disease, which is amenable to curative surgical resection. d) History of cardiac disease e) Uncontrolled hypertension and arterial or venous thrombotic disease f) Prior treatment with cabozantinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the benefit of cabozantinib in metastatic/Unresectable refractory Gastrointestinal stromal tumor, as determined by a 3-month progression-free rateTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 6 -month Progression-free survival rate 2. Overall survival (OS) 3. Response rates – Complete response (CR), Partial response (PR) 4. Safety 5. Quality of life (QoL) analysisTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Sameer Rastogi
All India Institute of Medical Sciences
Outcome results
None listed