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.

• Register: CTRI
• Last refreshed on: 4 May 2013
• Main ID: CTRI/2009/091/001016
• Date of registration: 13-01-2010
• Primary sponsor: Wockhardt Limited
• Public title: 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.
• Scientific title: Randomized, comparative, Phase III clinical trial to compare the efficacy and safety of recombinant human pegylated granulocyte colony stimulating factor(Peg G-CSF) versus granulocyte colony stimulating factor (G-CSF) in subjects with nonmyeloid malignancies receiving myelosuppressive chemotherapy.
• Date of first enrolment: 02-02-2010
• Target sample size: 108
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1152
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable

Countries of recruitment

India

Contacts

• Name: Dr Rakesh Chugh
• Affiliation: NA

• Name: Dr Ashima Bhatia
• Affiliation: NA

Key inclusion & exclusion criteria

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 _??Informed Consent Form_??

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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

NONMYELOID MALIGNANCIES RECEIVING MYELOSUPPRESSIVE CHEMOTHERAPY

Intervention(s)

Intervention1: Peg G-CSF: NA
Control Intervention1: Recombinant human G-CSF: Inj. Neupogen

Primary Outcome(s)

The primary efficacy end point will be the duration in days of the grade IV

neutropenia (defined as ANC _?_ 500 /mm3) in the present chemotherapy

cycle.Timepoint: 10 days

Secondary Outcome(s)

The secondary efficacy will be determined in terms of the following

secondary end points:

1. Incidence of febrile neutropenia

2. Incidence of intravenous antibiotic administration

3. Incidence of hospitalizationTimepoint: 10 days

Secondary ID(s)

P3-Peg G-CSF-02

Source(s) of Monetary Support

Wockhardt Limited, Wockhardt Towers, Bandra-Kurla Complex, Bandra (E), Mumbai 400051, India Tel: [phone] (O) Fax: [phone]