Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
Conditions
Interventions
Intervention1: Tablet Sunitinb TDM based dosing
: Starting dose 50 mg per day. Treatment regimen: 2/1 schedule for 2 weeks patient will be on treatment with sunitinib and for 1 week off the drug. Pat
Sponsors
Advanced Cancer for Treatment Research and Education
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adults of age 18 years and above 2 Histologically or cytologically proven mRCC 3 Chemo-naïve patients eligible for single agent sunitinib 4 Patient willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1 Patient with malignancies other than mRCC 2 Patient received one or more dose of sunitinib previously 3 Patients with active HIV infection and serology positive for HBV,HCV ,HAV 4 History of severe liver disease or other uncontrollable medical condition 5.Patients on concomitant drugs which are CYP3A4 inducers or inhibitors 6. Patients with ECOG PS more than or equal to 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate improved tolerability of sunitinib using TDM based dosing strategy compared to standard dosing strategy. Co-primary objective: To demonstrate non-inferiority of TDM based dosing strategy compared to standard dosing strategy in terms of progression free survival(PFS) Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the Overall survival (time of sunitinib started till death due to any cause) between the standard dosing regimen versus TDM based approach. 2. Cost analysis of therapeutic drug monitoring in individualizing sunitinib therapy. 3. To compare the quality of life of patients on TDM based individualized dosing of sunitinib versus standard dosing regimen of sunitinib. Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactVikram Gota
Advanced Centre for Treatment, Research and Education in Cancer
Outcome results
None listed