A clinical study to evaluate the safety and tolerability by using VRP-1620 in patients with solid tumors.
Phase 1
Completed
- Conditions
- Health Condition 1: null- Solid Tumor (Breast Cancer)
- Registration Number
- CTRI/2009/091/001006
- Lead Sponsor
- Venus Remedies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
1.Female subjects in the age group of 18- 65 years
2.Subjects with biopsy breast cancer
3.Performance status, Karnofsky performance score >70
4.Patients have an ANC >1500, Platelets >100000
5.Subjects willing to give written informed consent.
Exclusion Criteria
1.Patients with coagulopathy, history of stroke, deep vein thrombosis, cardiac dysfunction, uncontrolled hypertension, history of cardiac surgery, brain tumor or brain metastasis, and sarcomas
2.Patient with respiratory disorder
3.Pregnancy or lactation
4.Patients with abnormal renal & liver functions
5.Patients allergic to VRP-1620 and related products
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In Phase-Ito establish MTD (Dose at which at least one of three patients experiences a serious adverse event, whose association with VRP-1620 cant be rule outâ??.) <br/ ><br> <br/ ><br>To establish Safety by determining the Incidence of Adverse events <br/ ><br>To establish the Pharmacokinetic parametersTimepoint: Blood samples (1.0-2.0ml) shall be collected from breast cancer patients at following time intervals. 0min,5min,10min,15min,20min,30min, 45min, 60min,90min, 120min,180min and 360min. After that plasma shall be separated and VRP-1620 shall be analyzed for pharmacokinetic parameters like Cmax, Tmax, T1/2 half life, AUC and elimination constant
- Secondary Outcome Measures
Name Time Method Enhancement in Radiological detection of solid tumors in breast cancer patients.Timepoint: Percentage change in vessel diameter and Resistive index(RI) on Doppler examination before dosing and after dosing of VRP-1620