Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
None listed
Sponsors
Advanced Cancer for Treatment Research and Education in cancer
Eligibility
Inclusion criteria
Inclusion criteria: 1. Any cancer patient where nivolumab is indicated 2. Life expectancy greater than or equal to 3 months 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1(less than 2) 4. Adequate organ and marrow function as defined below: a. Adequate organ functions Absolute neutrophil count greater than 1,500/per microliter b. Platelets greater than 100,000/per microliter c. Hemoglobin greater than or equal to 9.0 g/dL d. Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin less than 3.0 mg/dL) e. Aspartate Aminotransferase (SGOT)/ Alanine Aminotransferase (SGPT) less than 3 X institutional ULN f. Creatinine less than or equal to 1.5 X institutional ULN OR Creatinine clearance greater than 40 mL/min for patients with creatinine Levels above institutional normal (calculated using the Cockcroft-Gault formula below) 5. Patients willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. History of severe hypersensitivity reaction to other antibody products 2. Adverse drug reactions (ADRs) associated with prior treatments or surgical therapy with a possible influence on the study outcome 3. Multiple primary cancers 4. Any active, known or suspected autoimmune disease 5. Documented history of any chronic or recurrent autoimmune disease or requirement for systemic steroids or immunosuppressants 6. Uncontrolled brain metastases. 7. History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 8. Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating ongoing acute or chronic infection. 9. Requiring systemic treatment with either corticosteroids (greater than 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration. 10. Pregnant or currently breastfeeding. 11. Receiving any other anticancer therapy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Nivolumab in Indian patients with malignant solid tumors.Timepoint: 0, 0.5 hr ,1 hr, 6 hr, 24hr, 72hr, 336hr, | — |
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the first dose and steady-state AUC of nivolumab in Indian patients with malignant solid tumors 2. To determine the exposure- toxicity relationship of nivolumab in Indian patients with malignant solid tumors. Timepoint: 0.5 hr, 1 hr, 6 hr, 12hr,24hr,72hr,,336hrs. | — |
Countries
India
Contacts
Public ContactVikramGota
ACTREC, Tata Memorial Centre
Outcome results
None listed