Health Condition 1: null- Solid Tumor (Breast Cancer)
Conditions
Interventions
Intervention1: VRP-1620: Slow intravenous bolus injection 50mcg/5ml
Control Intervention1: NIL: NIL
Sponsors
Venus Remedies Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In Phase-I to 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??.) To establish Safety by determining the Incidence of Adverse events 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Mohd Amin Mir
Venus Remedies Limited
Outcome results
None listed