Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.

January 18, 2018 updated by: Gema Biotech S.A.

A Randomized, Multicenter Clinical Trial to Determine the Efficacy, Safety and Tolerability of Peg-filgrastim (Gema) Compared to Peg-filgrastim (Roche) for Prevention of Chemotherapy Induced Neutropenia in Patients With Breast Cancer

This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eligible patients will be scheduled to receive a chemotherapy regimen with risk of febrile neutropenia ≥20%. Study drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMA BIOTECH, or Peg-Filgrastim of Roche).

A total of 4 or 6 cycles of chemotherapy supported by Peg-Filgrastim will be administered with an interval of three weeks between each cycle.

Patients will be followed up for 28± 3 days after the last dose of Peg-Filgrastim.

Hematological assessment (Absolute Neutrophil Count [ANC]) will be assessed on day 1 or up to -3 (before administration of anticancer chemotherapy), day 2 or 3 and 5 through 9 of the first cycle, and thereafter every day until post-nadir ANC recovery to ≥ 1.5 x 109/l following each cycle of chemotherapy. In the following cycles, hematological assessment shall be performed on day 1 or up to -3 (before administration of anticancer chemotherapy), on day 2 or 3 and on days 5 and 7. This schedule only applies if the subject did not develop Severe Neutropenia on the previous cycle. If the patient develops Severe Neutropenia on the first cycle or at any cycle, then the schedule corresponding to first cycle shall be followed.

During baseline (before the administration of Peg-Filgrastim), day 5 and day 9 following the first cycle of chemotherapy CD34+ (cluster of differentiation) count will be determined.

The study consists of:

  • Screening (up to 4 weeks)
  • Treatment period (6 cycles each of 3 weeks. i.e. a total of 18 weeks)
  • Follow up period for safety (4 weeks after Peg-Filgrastim last dose)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female patients aged 18 to 70 years old.
  • Patients diagnosed having high risk stage 2 or stage 3 or 4 of breast cancer (by histopathological or cytological diagnosis) and need neoadjuvant, adjuvant chemotherapy, or with metastatic disease.
  • A priori has been decided to be treated with Peg-Filgrastim and subjects eligible for Peg-Filgrastim therapy according to indications and clinical use in the product monograph
  • Patients scheduled to receive 4 or 6 cycles of chemotherapy (Taxane combinations) with prophylactic Peg-Filgrastim at 3 weeks interval. Monoclonal Antibodies in addition to Taxane regimens are permitted.
  • Any acute adverse effects of prior therapy must have resolved to ≤ NCI CTCAE (Version 4.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1
  • Eastern Cooperative Oncology Group - ECOG Performance Status 0, 1 or 2 as determined on Day 1 or up to -3 of Cycle 1 prior to administration of chemotherapy

  • Patients must have adequate organ function including the following:

    1. Adequate bone marrow functions, as determined within 3 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by Hb ≥9,5 g/dl (transfusion permitted to be included in the trial ),WBC (white blood cell) ≥3,5 x 109/l, Absolute neutrophil count (ANC) ≥1.5 x 109/l, Platelets ≥95 x 109/l;

    2. Adequate renal and hepatic function, as determined within 3 days prior to administration of chemotherapy on Day 1 of Cycle 1 and defined as follows,

      1. Hepatic: Bilirubin ≤ 1.5 x the upper limit of normal (ULN) (unless elevation is known to be due to Gilbert's disease), Subjects must also meet one of the following criteria:

        1. Alkaline phosphatase within normal reference range and both AST (aspartate aminotransferase) and ALT (alanine aminotransferase) >2.5 x ULN; or
        2. Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN; or
        3. Alkaline phosphatase <5 x ULN and both AST and ALT within normal reference range;
      2. Renal: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≤ 60 ml/min (calculated according to the Cockcroft and Gault formula)
  • Patients of child-bearing potential must have a negative pregnancy test within 3 days prior to the first dose of chemotherapy and at day 1 or up to -3 days of each Cycle) and use at least one form of contraception as approved by the investigator during the study.
  • Life expectancy >6 months

Exclusion Criteria:

Safety of treatment dependent criteria:

  • Presence of any serious concomitant systemic disorders incompatible with the administration of filgrastim, Peg-Filgrastim or any systemic disease that can influence the patient's safety according to doctor's diagnosis.
  • History of hypersensitivity to Peg-Filgrastim, filgrastim or E.coli derived proteins.
  • Serious local infection or active systemic infection within 10 days prior to enrollment or patients who have taken antibiotics within the previous 10 days
  • Pregnant or breast-feeding patients
  • Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
  • Known bleeding disorder
  • Patient known to have HIV, Hepatitis B, Hepatitis C or who have a positive serology for HIV, Hepatitis B or Hepatitis C at screening
  • History or presence of sickle cell disease
  • Concurrent or prior radiotherapy within four weeks of randomization

Criteria dependent on compliance with study procedures, or the evaluation of the response:

  • Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only)
  • Treatment with certain other agents to treat the malignant disease
  • Known drug addiction, including alcoholism
  • Treatment with any investigational product within 30 days prior to study drug administration
  • Concurrent prophylactic antibiotics
  • Previous participation in this study.
  • Already involved in another trial.
  • History of bone marrow or stem cell transplantation.
  • Previous therapy should not have included G-CSF (granulocyte-colony stimulating factor)

Previous participation in this study: Subjects who are considered screening failures are allowed to be re-screened, except if have started chemotherapy. In case of re-screening the following assessments and evaluations do not have to be repeated: Demographics, Medical history, HIV, Hepatitis B and C serology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peg-Neutropine®
Study drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMABIOTECH, or Peg-Filgrastim of Roche).
Drug: Peg-Filgrastim
Other Names:
  • Peg-Neutropine®
  • Neulastim®
Active Comparator: Neulastim®
Study drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMABIOTECH, or Peg-Filgrastim of Roche).
Drug: Peg-Filgrastim
Other Names:
  • Peg-Neutropine®
  • Neulastim®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Efficacy: Duration (in days) of severe neutropenia-DSN
Time Frame: Day 5 to day 9 of the first cycle
ANC (Absolute Neutrophil Count) < 500/mm3 in the first cycle of chemotherapy.
Day 5 to day 9 of the first cycle

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Efficacy: Incidence of severe neutropenia
Time Frame: Day 5 to Day 21 during 4 - 6 cycles
ANC (Absolute Neutrophil Count) <500/mm3 or 0.5 x 109/l not associated with fever across the cycles
Day 5 to Day 21 during 4 - 6 cycles
ANC nadir
Time Frame: Day 5 to Day 21 during 4 - 6 cycles
Determination of ANC decreasing (depth of ANC nadir) and time to the post nadir ANC recovery (ANC ≥ 1500 /mm3)
Day 5 to Day 21 during 4 - 6 cycles
Incidence of neutropenia
Time Frame: Day 5 to Day 21 during 4 - 6 cycles
Incidence of Grade 3 neutropenia (ANC <1000 - 500/mm3) . incidence of Febrile Neutropenia-FN [defined as ANC <1000/mm3 or 1.0 x 109/l and a single temperature of >38.3° C (101° F) or a sustained temperature of ≥38° C (100.4° F)] for more than one hour by cycle and across the cycles. incidence of ANC <500/mm3 and body temperature of >38.3°C.
Day 5 to Day 21 during 4 - 6 cycles
Fever
Time Frame: Day 5 to Day 21 during 4 - 6 cycles
Incidence of fever (temperature of >38.3° C - 101° F)
Day 5 to Day 21 during 4 - 6 cycles
infections
Time Frame: Day 5 to Day 21 during 4 - 6 cycles
Incidence of infections
Day 5 to Day 21 during 4 - 6 cycles
IV anti-infectives
Time Frame: Day 5 to Day 21 during 4 - 6 cycles
Incidence of need for IV anti-infectives
Day 5 to Day 21 during 4 - 6 cycles
Post-chemotherapy hospitalization
Time Frame: Day 5 to Day 21 during 4 - 6 cycles
Incidence and duration of post-chemotherapy hospitalization
Day 5 to Day 21 during 4 - 6 cycles
Hospitalization due to neutropenia
Time Frame: Day 5 to Day 21 during 4 - 6 cycles
Incidence and duration of hospitalization as a result of neutropenia
Day 5 to Day 21 during 4 - 6 cycles
Mortality
Time Frame: Day 5 to Day 21 during 4 - 6 cycles
Mortality due to infection
Day 5 to Day 21 during 4 - 6 cycles
Pharmacodynamics
Time Frame: Day 5 and 9 of the first cycle
The mobilization of CD34+ cells
Day 5 and 9 of the first cycle
Incidence of Adverse Drug Reactions (safety and tolerability) as assessed by CTCAE v4.0
Time Frame: Day 5 to Day 21 during 4 - 6 cycles
Frequency of patients who withdraw the study drug due to lack of tolerance Frequency of patients who withdraw the study drug treatment due to any reason Incidence of local tolerability at the injection site
Day 5 to Day 21 during 4 - 6 cycles
Immunogenicity
Time Frame: Day 5 and Day 28 of the last cycle
Neutralizing Antibody (NABs) Titer and Binding Antibodies (BABs) to Peg-Filgrastim (anti-rG-CSF [Recombinant Granulocyte-Colony stimulating factors] antibodies greater or equal to a determined concentration expressed in U/mL) will be measured using validated methods
Day 5 and Day 28 of the last cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gema Biotech S.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
QUID Quality in Drugs and Devices Latin American Consulting SRL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ezequiel Klimovsky, MD, QUID quality in drugs and devices LATAM consulting SRL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GEMPEGFIL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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