Clinical Trials Logo

Clinical Trial Summary

A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.

Adult patients (18 years of age or older) diagnosed as having any malignancy (except myeloid malignancy, ECOG status of 0-2 and having a history of experiencing neutropenia (absolute neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs would be recruited into the study.

Treatment will be initiated not earlier than 24 hours after the administration of cytotoxic chemotherapy in both groups.

Group 1: Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha)

- Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier Group 2: Neupogen (rhG-CSF)

- Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier Primary End Point would be to evaluate the percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of > 38°C twice in a 12-hour period and absolute neutrophil count < 0.5 x 109/L on the same day of the fever or the day after)in the two treatment groups.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00776165
Study type Interventional
Source Shantha Biotechnics Limited
Contact
Status Completed
Phase Phase 3
Start date October 2007
Completion date September 2009

See also
  Status Clinical Trial Phase
Completed NCT02643901 - Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects Phase 1
Completed NCT02251977 - Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer Phase 3
Terminated NCT02454530 - Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
Active, not recruiting NCT02104830 - Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients Phase 3
Completed NCT04914702 - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Active, not recruiting NCT03294577 - Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia Phase 3
Not yet recruiting NCT03701841 - Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis
Completed NCT03251768 - Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients Phase 2
Recruiting NCT04101760 - Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Phase 3
Completed NCT04134429 - Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy
Completed NCT04227990 - Plinabulin iv Solution in Prevention of TAC Induced Neutropenia Phase 2
Completed NCT03102606 - Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3 Phase 3
Completed NCT01569087 - Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients Phase 2
Completed NCT05512676 - Trabectedin/Caelyx vs Cisplatin Hypersensitivity in Relapsed Ovarian Cancer Patients Allergic to Platinum
Completed NCT04460079 - Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN
Recruiting NCT02725606 - Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer Phase 1
Completed NCT02692742 - Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia Phase 2
Completed NCT02532712 - Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers Phase 1
Completed NCT01516736 - Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim Phase 3
Terminated NCT04887831 - Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab Phase 2