Phase III clinical trial to compare the efficacy and safety of pegylated granulocyte colony stimulating factor(Peg G-CSF) versus granulocyte colony stimulating factor (G-CSF) in nonmyeloid malignancies subjects.

Phase 3

Completed

• Conditions: Health Condition 1: null- NONMYELOID MALIGNANCIES RECEIVING MYELOSUPPRESSIVECHEMOTHERAPY

• Registration Number: CTRI/2009/091/001016
• Lead Sponsor: Wockhardt Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

Inclusion:

The subjects included in the study should satisfy the inclusion criteria enlisted

below

1. Adult subject of either sex between age group of 18 to 65 years with histologically confirmed non myeloid malignant tumors undergoing a variety

of myelosuppressive chemotherapy regimens

2. Cancer subject with a good performance status (ECOG grade 0-2)

3. Subjects with >= 20% risk of developing chemotherapy induced febrile neutropenia. Subjects receiving chemotherapy regimens with intermediate to high risk for febrile

neutropenia are eligible.

4. No serious abnormality of hepatic or renal function at screening.

5. Subject willing to sign the â??Informed Consent Formâ??

Exclusion:

The following categories of subjects will be excluded from the study.

1. Subject with history or clinical evidence of serious benign medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the

Investigator with or without specific investigations.

2. Subject with body weight < 45 kg

3. Current therapy with other investigational drugs or lithium.

4. History or clinical evidence of congestive heart failure.

5. Prior treatment with interferons, interleukins or colony stimulating factors

(including G-CSF, GM- CSF, M-CSF and erythropoietin).

6. Subject who has been receiving radiation therapy within 4 weeks of randomization into the study.

7. Prior bone marrow or stem cell transplantation

8. Pregnant women, nursing women and women not practicing effective contraception.

9. Subject with known hypersensitivity to E-coli derived proteins or any component of the study medication.

Exclusion Criteria

1. Subject with history or clinical evidence of serious benign medical illnesses
including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or
hematologic disease as determined by the clinical judgment of the
Investigator with or without specific investigations.
2. Subject with body weight < 45 kg
3. Current therapy with other investigational drugs or lithium.
4. History or clinical evidence of congestive heart failure (NYHA class III-IV).
5. Prior treatment with interferons, interleukins, or, colony stimulating factors
(including G-CSF, GM- CSF, M-CSF and erythropoietin).
6. Subject who has been receiving radiation therapy within 4 weeks of
randomization into the study.
7. Prior bone marrow or stem cell transplantation
8. Pregnant women, nursing women and women not practicing effective contraception.
9. Subject with known hypersensitivity to E-coli derived proteins or any
component of the study medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified