Dose finding study to evaluate the pharmacodynamics, pharmacokinetics, efficacy and safety of balugrastim in pediatric patients diagnosed with solid tumors receiving chemotherapy.
- Conditions
- eutropenia induced by chemotherapy in patients with solid tumorsMedDRA version: 14.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-005432-28-CZ
- Lead Sponsor
- Teva Pharmaceuticals Industries Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
a. Histologically- or cytologically-confirmed solid tumor in a patient for whom the study chemotherapy regimen (vincristine plus ifosfamide plus doxorubicin plus etoposide [VIDE], vincristine plus doxorubicin plus cyclophosphamide alternating with ifosfamide plus etoposide [VDC/IE], ifosfamide plus vincristine plus actinomycin D [IVA] or ifosfamide plus vincristine plus adriamycin [IVAd]) is considered an appropriate treatment.
b. Minimum body weight (BW) of 15 kg
c. Life expectancy of at least 3 months with appropriate therapy
d. Female or male children and adolescents aged 2 to 17 years
e. Written informed consent provided by parent(s)/legal representative(s) of the pediatric patient and patient’s assent if appropriate at the time of screening.
f. Fertile patients (male or female) must use highly reliable contraceptive measures (ie, two of the following: oral contraception, implants, injections, barrier contraception, and intrauterine device, or vasectomized/sterilized partners, or sexual abstinence). For the purposes of this study, a fertile female patient is any female patient who has experienced menarche and who has not undergone tubal ligation.
g. Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
h. White blood cell (WBC) count >2.5 x 10(9)/L, absolute neutrophil count (ANC) =1.5 x 10(9)/L, and platelet count =100 x 10(9)/L (at screening and prior to chemotherapy)
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
a. Primary myeloid disorders
b. Previous chemotherapy or wide-field irradiation to the pelvis
c. Previous exposure to filgrastim, pegfilgrastim, lenograstim or other granulocyte-colony stimulating factor (G-CSF) less than 6 months before randomization.
d. Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim or any balugrastim excipients
e. Pregnancy or breastfeeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
f. Major surgery, serious infection, serious trauma or compound medical procedure within the 4 weeks prior to the first study drug dose.
g. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, electrocardiogram (ECG), laboratory tests or imaging.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim during Cycle 1 in children receiving chemotherapy.;Secondary Objective: • To document the duration of severe neutropenia (DSN) and the incidence of febrile neutropenia in Cycle 1 of chemotherapy<br>• To assess safety, tolerability and immunogenicity of balugrastim.;Primary end point(s): 1.Area under the curve of ANC (AUCANC)<br>2.DSN<br>3.Incidence of severe neutropenia<br>4.Frequency of febrile neutropenia (defined as body temperature >38.5°C for more than one hour [axillary measurement] and ANC <0.5 x 10(9)/L) by cycle<br>5. Pk endpoints as per Protocol;Timepoint(s) of evaluation of this end point: 1.Cycle 1<br>2-3.Cycles 1-4<br>4.Cycles 1-4<br>5.Cycle 1
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • ANC (absolute neutrophil count) nadir (measured in 10(9)/L), which is the lowest ANC recorded<br>• Time to ANC nadir, which is the time from the beginning of chemotherapy up to the occurrence of the ANC nadir<br>• Time to ANC recovery (ANC >1.5 x 10(9)/L) from nadir in all treatment cycles;Timepoint(s) of evaluation of this end point: All treatment cycles