Addition of Everolimus to Standard of Care in Carcinoma Gallbladder
- Conditions
- Health Condition 1: C23- Malignant neoplasm of gallbladder
- Registration Number
- CTRI/2023/05/052625
- Lead Sponsor
- BH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Histological proof of cancer with stage III inoperable or Stage IV metastatic disease without any prior treatment.
Patients with histologic proof of metastatic gallbladder carcinoma who have not had previous treatment for metastatic disease or who received gemcitabine/capecitabine with or without platinum more than months ago as part of adjuvant therapy
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness orsocial situations that would limit compliance with study requirements
Clinically significant cardiac disease, especially history of myocardial infarction more than 6 months, or congestive heart failure (New York Heart Association [NYHA] classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Patients taking strong inhibitors or inducers of CYP3A4
Prior therapy with everolimus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival <br/ ><br>Overall survival <br/ ><br>Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method Toxicity as per WHO toxicity criteriaTimepoint: Every 3 weeks