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

NCT ID: NCT01940601

Last Updated: 2015-01-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-31

Brief Summary

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.

Conditions

Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Balugrastim 300 ug/kg

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

Group Type: EXPERIMENTAL

Balugrastim

Intervention Type: DRUG

Balugrastim 300 ug/kg and Balugrastim 670 ug/kg

Balugrastim 670 μg/kg

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

Group Type: EXPERIMENTAL

Balugrastim

Intervention Type: DRUG

Balugrastim 300 ug/kg and Balugrastim 670 ug/kg

Filgrastim 5 μg/kg

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.

Group Type: ACTIVE_COMPARATOR

Filgrastim

Intervention Type: DRUG

Filgrastim 5 μg/kg

Interventions

Balugrastim

Balugrastim 300 ug/kg and Balugrastim 670 ug/kg

Intervention Type: DRUG

Filgrastim

Filgrastim 5 μg/kg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NEUGR-005

Identifier Type: -

Identifier Source: org_study_id