A clinical trial to study the effects of two drugs Peg G-CSF and Grafeel® in the prevention of reduction in neutrophil counts in cancer patients caused by drugs used to treat cancer.

Phase 3

Recruiting

• Registration Number: CTRI/2009/091/000694
• Lead Sponsor: DR.REDDY'S LABORATORIES LTD.Biologics Development Centre , Survey No.47, Bachupalli, Qutubullapur, Hyderabad-500090, A.P, IndiaFax: +91-40-44644507, 91-40-23041418

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1)Signed and dated written informed consent
2)Patients aged 18 to 70 years
3)Chemo naive patients
4)Patients diagnosed with unresectable stage IIIB or IV NSCLC or metastatic breast cancer requiring first line cytotoxic chemotherapy regimen associated with intermediate risk of febrile neutropenia and significant risk of severe neutropenia
5)Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
6)Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^9/L and Platelets greater than or equal to 100 x 10^9/L
7)Adequate liver function: bilirubin less than or equal to 1.5mg/dL, ALT/AST/ alkaline phosphatase less than 2 times the upper normal value (unless due to liver involvement in which case ALT/AST less than 4 times the upper normal value, and alkaline phosphatase without limit)
8)Adequate renal function: serum creatinine less than or equal to 1.5 mg/dL and GFR greater than or equal to 50 ml/min
9)If female:
Women without childbearing potential (eg. Post menopausal, surgery/ radiation therapy terminating reproductive potential etc)
OR
Women with childbearing potential using an approved contraceptive method (intrauterine device, birth control pills, or barrier device) during and for 3 months after completion of study, and having negative urine Beta-HCG test prior to study enrolment

Exclusion Criteria

1)Any clinically significant findings on history or examination that, in the opinion of the investigator, would preclude administration of chemotherapy and Grafeel®/ Peg G-CSF therapy in the full doses and clinically significant cardiac disease, neuropathy or other disease
2)Any active cancer or history of prior malignancy except carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin or any surgically cured malignancies diagnosed 5 years or more before screening
3)Patients with Congestive Heart Failure class III/IV as per New York Heart Association classification
4)LVEF <50%, except patients receiving doxorubicin containing chemotherapy, wherein LVEF <55%
5)Clinically symptomatic brain metastases
6)A positive serologic test for the Human Immunodeficiency Virus (HIV) or unresolved Hepatitis B or C virus infection
7)Pregnant or breast-feeding women
8)Patients who have received any other investigative drugs within 30 days before randomization
9)History of allergic reactions to the study drug or its constituents
10)Previous exposure to any colony stimulating factor
11)Patients previously diagnosed with sickle cell disorder
12)Chronic use of oral corticosteroids (except low dose with no more than 20 mg/d prednisolone or equivalent for COPD)
13)Any illness or condition that in the opinion of the investigator could affect the safety of the patient
14)Radiation therapy within 4 weeks of randomization into this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of severe (grade 4) neutropenia in cycle 1.Timepoint: 3 weeks

Secondary Outcome Measures

Name	Time	Method
ANC nadir, defined as patients lowest ANC for cycle 1.Timepoint: 3 weeks;Incidence of febrile neutropenia (FN) by cycle and across all cycles.Timepoint: 18 weeks;Incidence of severe neutropenia by cycle and across all cycles.Timepoint: 18 weeks;Time to ANC recovery, defined as the time in days from chemotherapy administration until patients ANC increased to ≥ 2.0 X 109/l after the expected nadir for cycle 1.Timepoint: 3 weeks