Health Condition 1: null- Patients suffering from chemotherapy induced Neutropenia
Conditions
Interventions
Intervention1: R-TPR-029: Dose:6 mg, Frequency Every 21 days, Route of administration is subcutaneous, Duration 4 cycles (of 21 days each)
Control Intervention1: Neulasta® (Neulastim®): Dose 6 mg,
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients of either sex in the age group of 18 to 65 years 2. Patients scheduled to receive myelosuppressive chemotherapy regimens. 3. Any previous chemotherapy exposure should have been completed >3 weeks before randomization and no more than 1 cycle of chemotherapy for the existing disease is allowed before randomization into the present study. 4. Patients with high risk or intermediate risk of developing chemotherapy-induced febrile neutropenia as per NCCN guidelines. 5. Patients planned and eligible to undergo at least 4 cycles of chemotherapy after randomization. 6. Eastern Cooperative Oncology Group (ECOG) performance status 7. Adequate hematologic function 8. Estimated life expectancy >6 months 9. Females of childbearing potential should be willing to use an approved method of contraception. 10. Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
Exclusion criteria
Exclusion criteria: 1. Known active acute or chronic infection 2. Pregnant or breastfeeding women, and women not practicing effective contraception. 3. Known hypersensitivity to the active ingredient or other product constituents. 4. Patients with history of radiation within 4 weeks before the first cycle of chemotherapy in the study 5. Patient is on bleomycin- or carbazitaxel-containing chemotherapy regimen 6. Patient with body weight 45 kg 7. Previous bone marrow or stem-cell transplantation 8. Diagnosis of concurrent second malignancy 9. Serious inter-current chronic or acute illness 10. Systemic autoimmune disorder and/or chronic use of immunosuppressive agents during the 6 weeks prior to the first cycle of chemotherapy in the study 11. History of chemotherapy causing delayed myelosuppression 12. Concurrent use of other granulocyte colony stimulating growth factors 13. Received prophylactic antibiotics within the preceding 6 weeks. 14. Patients with neuropathy of grade 2 or higher. 15. Impaired renal or hepatic function. 16. Any other medical condition, which in opinion of the investigator, may affect patientâ??s participation in the study 17. Patientâ??s participation in another clinical trial 90 days prior to administration of IP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of Grade 4 neutropenia will be measured in days in patients receiving R-TPR-029 / Neulasta® (Neulastim®)Timepoint: Duration of Grade 4 neutropenia will be measured in days in patients receiving R-TPR-029 / Neulasta® (Neulastim®) | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Incidence of Grade 4 neutropenia . â?¢ The incidence of febrile neutropenia. â?¢ The duration of febrile neutropenia in Cycles 1 to 4. â?¢ Time to ANC recovery in days after the ANC nadir. â?¢ Depth of ANC nadir â?¢ Evaluation of safety upto 6 months after the first dose of PEG-GCSF in the study â?¢ Immunogenicity assessment Timepoint: 2nd, 3rd & 4th cycle of chemotherapy | — |
Countries
India
Contacts
Public ContactDr Sanjeev Hegde
Reliance Life Sciences Pvt. Ltd
Outcome results
None listed