- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01940601
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors
January 13, 2015 updated by: Teva Branded Pharmaceutical Products R&D, Inc.
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Balugrastim 300 ug/kg
Balugrastim 300 μg/kg subcutaneously (SC) administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles
|
Balugrastim 300 ug/kg and Balugrastim 670 ug/kg
|
Experimental: 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
|
Balugrastim 300 ug/kg and Balugrastim 670 ug/kg
|
Active Comparator: 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.
|
Filgrastim 5 μg/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve (AUC) of absolute neutrophil count (ANC)
Time Frame: Day 1 to 14
|
Day 1 to 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ANC nadir
Time Frame: Baseline to Week 16
|
ANC nadir (measured in 10^9/L), which is the lowest ANC recorded
|
Baseline to Week 16
|
Time to ANC nadir
Time Frame: Baseline to Week 16
|
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
|
Time to ANC recovery
Time Frame: Baseline to Week 16
|
Time to ANC recovery (ANC >1.5*10^9/L) from nadir within each treatment cycle
|
Baseline to Week 16
|
Duration of severe neutropenia (DSN)
Time Frame: Baseline to Week 16
|
Number of days subject experiences severe neutropenia (ANC <0.5*10^9/L)
|
Baseline to Week 16
|
Incidence of severe neutropenia
Time Frame: Baseline to Week 16
|
Proportion of subjects who experience severe neutropenia (ANC <0.5*10^9/L)
|
Baseline to Week 16
|
Frequency of febrile neutropenia
Time Frame: Baseline to Week 16
|
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
|
Summary of Participants with Adverse Events
Time Frame: From signing of informed consent to 16 weeks
|
From signing of informed consent to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Anticipated)
November 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
September 9, 2013
First Submitted That Met QC Criteria
September 9, 2013
First Posted (Estimate)
September 12, 2013
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEUGR-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Solid Tumors
-
Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
-
National Cancer Institute (NCI)RecruitingSolid Tumor | Refractory Solid Tumors | Malignant Solid Tumors | Other Neoplasms Solid Tumors | Pediatric Solid TumorUnited States
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Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
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Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
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Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
-
Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
-
NeuPharma, Inc.RecruitingLocally Advanced Solid Tumors | Metastatic Solid TumorsUnited States
-
AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
-
NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
Clinical Trials on Balugrastim
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedChemotherapy-induced Neutropenia
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedChemotherapy-induced NeutropeniaBulgaria, Romania, Russian Federation, Serbia, Ukraine