Health Condition 1: null- Patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia
Conditions
Interventions
Intervention1: Lupins Pegfilgrastim: Each patient will receive Lupins Pegfilgrastim of 6 mg injection by SC route, once in each chemotherapy cycle for 3 chemotherapy cycles. Pegfilgrastim, manufacture
Sponsors
Lupin Limited Biotechnology Division
Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must be able and willing to give written informed consent prior to any study-related procedures. 2. Male or non-pregnant / non-lactating female patients between 18-75 years of age. 3. Patients with histologically or cytologically confirmed nonmyeloid malignancies (Breast cancer, Non-Small Cell Lung Cancer, Non-Hodgkinâ??s Lymphoma, Head and neck cancer, Ovarian cancer, Bladder cancer) 4. Patients who are planned and eligible to receive myelosuppressive chemotherapy regimen that contains at least one chemotherapeutic agent from docetaxel/ paclitaxel/ doxorubicin/ epirubicin. 5. Patients who have not received myelosuppressive chemotherapy within last 12 months of screening. 6. Patients with baseline ANC of >= 1.5 x 109/L and platelet count >= 100 x 109/L 7. Patients with ECOG Performance status of 0 or 1
Exclusion criteria
Exclusion criteria: 1. Patients weighing 45 Kg 2. Patients with history of hypersensitivity to study drugs,components or similar products 3. Patients with myeloid malignancies and myelodysplasia 4. Patients currently receiving radiation therapy or have completed radiation therapy within 4 weeks before study entry 5. Patients with prior bone marrow or stem cell transplantation. 6. Patients with chronic use of oral corticosteroids. (Except 7. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy. 8. Patients with any active infection which may require systemic antimicrobial therapy 9. Patients who have received hematopoietic growth factors(e.g. G-CSF, pegGCSF, erythropoietin) or cytokines (e.g. interleukins, interferons) within last 1 month of screening 10. Patients with inadequate hepatic and renal function [defined as Alkaline Phosphatase 2.5 X Upper limits of normal(ULN), serum SGOT 2.5 X ULN, SGPT 2.5 X ULN,Total bilirubin 1.5 X ULN and Creatinine 1.5 X ULN of the reference range at the screening assessment] 11. Patients with seropositivity for HIV or HBV or HCV 12. Known cases of Sickle Cell Anemia 13. Patients with radiographic evidence of active pulmonary infections and/or recent history of pneumonia within 1 month of screening. 14. Patients with clinically evident splenomegaly confirmed subsequently by ultrasonography. 15. Patients with any other clinically significant disease(s)which, in the opinion of the investigator, could compromise the patientâ??s involvement in the study or overall interpretation of the data. [for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, metabolic, pulmonary, cardiovascular disease/impaired functioning or history of any autoimmune disease] 16. Patients who have participated in another therapeutic clinical study within the past 30 days prior to screening, or are likely to simultaneously participate in another therapeutic clinical study. 17. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons. 18. Women of child-bearing potential & all men who are not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 1 month after the last visit. 19. Patients with Congestive Heart Failure Class III/IV as per NYHA Classification.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of severe neutropenia in cycle 1 of chemotherapyTimepoint: Cycle 1 of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Febrile Neutropenia (FN) Neutropenia Duration of Severe Neutropenia Safety Adverse event (AE) assessment Rate of discontinuation Changes from baseline in vital signs and laboratory parametersTimepoint: Cycle 1, 2 and 3 of chemotherapy | — |
Countries
India
Contacts
Public ContactDr Dipak Patil
Lupin Limited
Outcome results
None listed