Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors

Teva Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Solid Tumors

Treatments: Drug: Balugrastim; Drug: Filgrastim

Study type: Interventional

Funder types: Industry

Identifiers

NCT01940601

NEUGR-005

Details and patient eligibility

About

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 in children receiving chemotherapy.

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histological 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.
2. Minimum body weight of 15 kg
3. Life expectancy of at least 3 months with appropriate therapy
4. Female or male children and adolescents aged 2 to 17 years
5. 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.
6. Fertile patients (male or female) must use highly reliable contraceptive measures.
7. Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
8. White blood cell (WBC) count >2.5*10^9/L, ANC ≥1.5*10^9/L, and platelet count ≥100*10^9/L (at screening and prior to chemotherapy)

Exclusion criteria

1. Primary myeloid disorders
2. Prior radiation therapy within 4 weeks of randomization into this study.
3. Previous exposure to filgrastim, pegfilgrastim, lenograstim or other G-CSF less than 6 months before randomization.
4. Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim or any balugrastim excipients
5. Pregnancy or breastfeeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
6. Major surgery, serious infection, within 3 weeks before first administration of study drug, serious trauma or compound medical procedure within the 4 weeks prior to the first study drug dose.
7. 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, ECG, laboratory tests or imaging.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Balugrastim 300 ug/kg

Experimental group

Description:

Balugrastim 300 μg/kg subcutaneously (SC) administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles

Treatment:

Drug: Balugrastim

Balugrastim 670 μg/kg

Experimental group

Description:

Balugrastim 670 μg/kg (maximum 40 mg) SC administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles

Treatment:

Drug: Balugrastim

Filgrastim 5 μg/kg

Active Comparator group

Description:

Filgrastim will be administered at a dose of 5 μg/kg SC once a day for at least 5 consecutive days or until absolute neutrophil count (ANC) has returned to ≥2\*10\^9/L for each chemotherapy cycle up to 4 cycles. The maximum period of filgrastim administration is 14 days in each cycle.

Treatment:

Drug: Filgrastim