A Study to Assess Effectiveness and Safety of Lupinâ??s Pegfilgrastim Versus Amgenâ??s Neulastim to prevent Neutropenia (a low number of neutrophils) caused by chemotherapy in patients with non-myeloid malignancies (type of cancer which do not involve or affect bone marrow).
- Conditions
- Health Condition 1: null- Patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinicallysignificant incidence of febrile neutropenia
- Registration Number
- CTRI/2012/01/002338
- Lead Sponsor
- upin Limited Biotechnology Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 170
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
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 <= 20 mg/day dose of prednisolone)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method