Cabozantinib in Advanced Gastrointestinal Stromal Tumor

Phase 2

• Conditions: Health Condition 1: C49A- Gastrointestinal stromal tumor

• Registration Number: CTRI/2024/06/068636
• Lead Sponsor: I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <1.5xULN, and eGFR >30ml/min)

g) Total bilirubin < 2.5x institutional ULN, ALT and AST <2.5 x ULN, alkaline phosphatase <2.5 x

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified