CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF VRP 1620 IN PATIENTS OF BREAST CANCER.
- Conditions
- Health Condition 1: null- breast cancer
- Registration Number
- CTRI/2013/07/003854
- Lead Sponsor
- Venus Remedies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
Female subjects in the age group of 18-65 years
Subjects presenting for routine breast cancer examination
Subjects with suspected clinical diagnosis of breast cancer
Subjects who have not undergone any biopsy for breast cancer
Subjects willing to give written informed consent
Subjects with coagulopathy history of stroke deep vein thrombosis cardiac dysfunction uncontrolled hypertension history of cardiac surgery brain tumor or brain metastasis, and sarcomas
Subject with respiratory disorder
Pregnancy or lactation
Subject has undergone a breast augmentation or breast implant
Subject has significant existing breast trauma
Subjects with abnormal renal & liver functions
Subjects allergic to VRP-1620 and related products
A marked baseline prolongation of QT/QTc interval eg repeated demonstration of a QTc interval grater then 450 milliseconds (ms)
A history of additional risk factors for TdP eg heart failure, hypokalemia, family history of Long QT Syndrome)
The use of concomitant medications that prolong the QT or QTc interval.
Subject has any other condition or personal circumstance that, in the judgment of the
investigator, might interfere with the collection of complete good quality data
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method