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

Solid Tumors Clinical Trial

Official title:

An Open Label, Randomized, Active Controlled, Dose Finding Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim at Doses of 300 µg/kg and 670 µg/kg in Pediatric Patients Diagnosed With Solid Tumors Receiving Chemotherapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01940601
• Other study ID #: NEUGR-005
• Status: Withdrawn
• Phase: Phase 2
• First received: September 9, 2013
• Last updated: January 13, 2015
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Ministry of HealthHungary: National Institute of PharmacyRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationUkraine: Ministry of HealthPoland: Ministry of HealthGeorgia: Ministry of HealthCzech Republic: State Institute for Drug ControlSlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• Balugrastim
Balugrastim 300 ug/kg and Balugrastim 670 ug/kg
• Filgrastim
Filgrastim 5 µg/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of absolute neutrophil count (ANC)		Day 1 to 14	No
Secondary	ANC nadir	ANC nadir (measured in 10^9/L), which is the lowest ANC recorded	Baseline to Week 16	No
Secondary	Time to ANC nadir	Time to ANC nadir, which is the time from the beginning of chemotherapy up to the occurrence of the ANC nadir	Baseline to Week 16	No
Secondary	Time to ANC recovery	Time to ANC recovery (ANC >1.5*10^9/L) from nadir within each treatment cycle	Baseline to Week 16	No
Secondary	Duration of severe neutropenia (DSN)	Number of days subject experiences severe neutropenia (ANC <0.5*10^9/L)	Baseline to Week 16	No
Secondary	Incidence of severe neutropenia	Proportion of subjects who experience severe neutropenia (ANC <0.5*10^9/L)	Baseline to Week 16	No
Secondary	Frequency of febrile neutropenia	Frequency of febrile neutropenia (defined as body temperature >38.5°C for more than one hour [axillary measurement] and ANC <0.5*10^9/L) by cycle and across all cycles.	Baseline to Week 16	No
Secondary	Summary of Participants with Adverse Events		From signing of informed consent to 16 weeks	Yes