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

NCT01940601 | Withdrawn Phase 2 DMC

• 1 other identifier: NEUGR-005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

solid tumors; balugrastim

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of absolute neutrophil count (ANC)

  Day 1 to 14

Secondary Outcomes (7)

• ANC nadir

  Baseline to Week 16

• Time to ANC nadir

  Baseline to Week 16

• Time to ANC recovery

  Baseline to Week 16

• Duration of severe neutropenia (DSN)

  Baseline to Week 16

• Incidence of severe neutropenia

  Baseline to Week 16

Study Arms (3)

Balugrastim 300 ug/kg

EXPERIMENTAL

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

Drug: Balugrastim

Balugrastim 670 μg/kg

EXPERIMENTAL

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

Drug: Balugrastim

Filgrastim 5 μg/kg

ACTIVE COMPARATOR

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.

Drug: Filgrastim

Interventions

Balugrastim DRUG

Balugrastim 300 ug/kg and Balugrastim 670 ug/kg

Balugrastim 300 ug/kg; Balugrastim 670 μg/kg

Filgrastim DRUG

Filgrastim 5 μg/kg

Filgrastim 5 μg/kg

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Minimum body weight of 15 kg
• Life expectancy of at least 3 months with appropriate therapy
• Female or male children and adolescents aged 2 to 17 years
• 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.
• Fertile patients (male or female) must use highly reliable contraceptive measures.
• Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
• 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)

You may not qualify if:

• Primary myeloid disorders
• Prior radiation therapy within 4 weeks of randomization into this study.
• Previous exposure to filgrastim, pegfilgrastim, lenograstim or other G-CSF less than 6 months before randomization.
• Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim or any balugrastim excipients
• Pregnancy or breastfeeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
• 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.
• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Interventions

balugrastim; Filgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 14, 2015

Record last verified: 2015-01