A non comparative, multicentre, repeat dose safety in use study of Neukine® (Filgrastim) in patients receiving chemotherapy known to induce neutropenia

• Conditions: Febrile neutropenia in breast cancer patients undergoing TAC chemotherapy; MedDRA version: 9.1Level: LLTClassification code 10016288Term: Febrile neutropenia

• Registration Number: EUCTR2007-005034-36-PL
• Lead Sponsor: Kwizda Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1.Female, =18 of age, suitable and intended to undergo adjuvant TAC (docetaxel, doxorubicin, cyclophosphamid) chemotherapy;

2.Body weight of subject must be within 40 and 120 kg

3.Subjects are within 60 days after the complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS)

4.Subjects with stage IIA, IIB or IIIA breast cancer

5.Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status = 2

6.Subjects who are chemotherapy naive

7.Subjects must have an absolute neutrophil count (ANC) =1.5 x 109/l; platelet count =100 x 109/l

8.Subject must have an adequate renal (serum creatinine <1.5 x upper limit) and hepatic function (bilirubin < upper limit of normal, transaminases <1.5 x upper limit and ALP within 1.5 x ULN)

9.Subjects have to have a normal cardiac function as evidenced by a LVEF >55%

10.Has no evidence of metastatic disease outside of breast by physical examination and chest x-ray. Other scans if done as needed by the patient (e.g. bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease

11.Has had baseline bilateral mammography

12.Females must not intend to conceive during or shortly after the study. They must be either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control (e.g., hormonal contraceptives, intrauterine device, or spermicide and barrier) and be willing to continue the same method of birth control during and for 30 days after the last dose of study medication

13.Females of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose of study drug

14.Willing and able to give written informed consent

15.Willing and able to undergo procedures required by this protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Has any evidence of metastatic disease following surgical resection of the primary tumor including: positive surgical margins, staging work-up, or physical examination suspicious for malignant disease (M1 disease on TNM staging system)

2.Has bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal or lobular, of the contralateral breast.

3.Has a history of severe hypersensitivity reaction to drugs intended to use in this protocol

4.Has had neoadjuvant chemotherapy for this breast cancer

5.Has ever had a myocardial infarction (MI) or has a history of heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes

6.Is receiving concurrent immunotherapy, hormonal therapy (e.g., tamoxifen, hormone replacement therapy), or radiation therapy

7.Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days

8.Has peripheral neuropathy >Grade 1

9.Has had a major organ allograft or condition requiring chronic immunosuppression (i.e., kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients who have received corneal transplants or cadaver skin or bone transplants are eligible.

10.Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Investigator to be clinically significant, precluding informed consent

11.Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive

12.Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin, carcinoma in situ of uterine cervix, DCIS, which could affect the diagnosis or assessment of any of the study drugs

13.Is pregnant or breastfeeding

14.Is receiving antibiotic treatment 3 days within chemotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the safety of Neukine® (Filgrastim) used for the prophylaxis of febrile neutropenia in breast cancer patients undergoing TAC chemotherapy as compared to the safety profile of approved/registered products.;Secondary Objective: ;Primary end point(s): Primary Safety endpoint:<br>The primary safety endpoint will be the subject incidence of adverse events (all severe and serious) classified by body system, preferred term, frequency, and relationship to study drug. Vital signs, the presence of antibodies and clinical laboratory results will also be monitored.<br><br>Efficacy endpoints:<br>The main efficacy endpoint will be the duration of severe neutropenia in cycle 1. Severe neutropenia is defined as occurrence of ANC below 0.5 x 109/L.