None listed
Conditions
Interventions
Intervention1: PEGFILGRASTIM: 6 mg single injection subcutaneously following chemotherapy for 3 cycles
Control Intervention1: NIL: NIL
Sponsors
GENNOVA BIOPHARMACEUTICALS LTD
Eligibility
Inclusion criteria
Inclusion criteria: Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study Patients able to adhere to the study visit schedule and other protocol requirements Patients aged 18 years and above Male patients or non-pregnant, non-lactating females Nonmyeloid cancer patients receiving chemotherapy regimens Patients with serum creatinine < 4.5 mg/dL, serum aspartate aminotransferase [AST] < 120 IU/L and alanine aminotransferase [ALT] < 120 IU/L (all values <3 times ULN)
Exclusion criteria
Exclusion criteria: Women who are pregnant, lactating or of child bearing potential who are not practicing effective methods of contraception Patients hypersensitive to study drugs, components or similar products. Patients with severe chronic neutropenia Patients with myeloid malignancies and myelodysplasia Patients currently receiving radiation therapy or have completed radiation therapy within 14 days before study entry Patients participated in another therapeutic clinical study (i.e., not an epidemiological study or genomic screening study) during the past 30 days, or are likely to simultaneously participate in another therapeutic clinical study &#61656; Patients with any active infection requiring systemic antimicrobial therapy &#61656; Known HIV or hepatitis patients &#61656; History or clinical evidence of a serious medical illness, including renal, hepatic, respiratory, cardiovascular, endocrine, neurologic, psychiatric, hematologic disease, which in the opinion of the investigator will interfere with study participation or with evaluation of the study results &#61656; History of, or known current problems with, substance abuse, or any medical, psychological, and/or social condition that may interfere with the patient's participation in the study &#61656; Any condition that could jeopardize the patient's safety and compliance, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutropenia GradeTimepoint: Day 3, 7, 10 & 14 after test drug for 3 chemotherapy cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and duration of febrile neutropeniaTimepoint: Day 3, 7, 10 & 14 after test drug for 3 chemotherapy cycles | — |
Countries
India
Contacts
Public ContactDr Bhagwat Gunale
EMCURE
Outcome results
None listed