A clinical study to assess the effect of Lupin?s Filgrastim as compared to Neupogen®(Amgen) administered after chemotherapy to prvent Neutropenia caused by chemotharapy in patients with non-myeloid malignancies
- Conditions
- Health Condition 1: null- Chemotherapy Induced neutropenia
- Registration Number
- CTRI/2011/05/001748
- Lead Sponsor
- PIN LIMITED BIOTECHNOLOGY DIVISIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 98
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 18-65 years of age
3.Patients with histologically or cytologically confirmed non-myeloid malignancy
4.Patients planned to have myelosuppressive chemotherapy regimen that consist at least one chemotherapeutic agent from docetaxel, doxorubicin or paclitaxel.
5.Patients who have not received myelosuppressive chemotherapy within last 12 months of screening.
6.Patients with baseline ANC of ¡Ý 1 x 109/L and platelet count ¡Ý 100 x 109/L.
7.Patients with adequate hepatic and renal function [defined as Alkaline Phosphatase ¡Ü 5 X Upper limits of normal (ULN), serum SGOT and SGPT ¡Ü 2.5 X ULN (¡Ü 5 X ULN for patient with liver involvement) , Total bilirubin ¡Ü 1.5 X ULN and Creatinine ¡Ü 1.5 X ULN of the reference range at the screening assessment]
8.Patients with ECOG Performance status of 0 or 1
1.Patients with history of hypersensitivity to study drugs, components or similar products.
2.Patients with myeloid malignancies and myelodysplasia
3.Patients currently receiving radiation therapy or have completed radiation therapy within 4 weeks before study entry
4.Patients with prior bone marrow or stem cell transplantation.
5.Patients with chronic use of oral corticosteroids. (Except ¡Ü 20 mg/day dose of prednisolone).
6.Patients with underlying neuropathy of Grade 2 or higher.
7.Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy. [However if patient is receiving antibiotics during screening, then chemotherapy can be started after 72 hours of last antibiotic dose.
8.Patients with any active infection which may require systemic antimicrobial therapy during the study.
9.Patients who have received hematopoietic growth factors (e.g. G-CSF, peg-G-CSF, erythropoietin) or cytokines (e.g. interleukins, interferons) within last 1 month of screening.
10.Known cases of HIV or HBV or HCV seropositive patients.
11.Known cases of Sickle Cell Anemia.
12.Patients with radiographic evidence of active pulmonary infections and/or recent history of pneumonia within 1 month of screening.
13.Patients with clinically evident splenomegaly confirmed subsequently by ultrasonography.
14.Patients with any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the patient¡¯s involvement in the study or overall interpretation of the data.
15.Alcoholic or drug abuse patients.
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.
20.LVEF 50 % , except patients receiving doxorubicin containing Chemotherapy, wherein LVEF 55 %
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Duration of severe neutropenia [ANC 0.5 x 109/L] in cycle 1 of chemotherapyTimepoint: Day 1, 2, 4 to 10, 15, 21(Cycle 1)
- Secondary Outcome Measures
Name Time Method assement of the neutropenia observed in the study with respect to DSN in cyecle 2, percentage of patients with neutrpoenia in the study, depth of ANC Nadir, time to ANC recoveryTimepoint: Day 1, 2, 4 to 10, 15, 21(Cycle 2);Incidence of Febrile Neutropenia (FN)by cycle and across the cycles, duration of FN, Rate of the hospitalization due to FN, percentage of the patients requiring system antibiotic to treat FN by cycle and acrros the cycleTimepoint: In both the cycles, day 1 to day 21;Safety: <br/ ><br>â?¢Adverse event (AE) assessment (as per NCI CTCAE Ver.4.0) <br/ ><br>â?¢Rate of discontinuations (proportion of patients who discontinue study treatment due to adverse events) <br/ ><br>â?¢Clinically significant Changes in laboratory parameters and physical examinations. <br/ ><br>Timepoint: At every patient visit in the study