Status:
COMPLETED
A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Neutropenia
Eligibility:
All Genders
1-16 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children and adolescents...
Eligibility Criteria
Inclusion
- Inclusion:
- Male or female infants, children and adolescents aged 1 month to \<16 years.
- Patients with solid tumors without bone marrow involvement, who are scheduled to receive myelosuppressive CTX.
- Body weight ≥5 kg.
- Patients must have an initial diagnosis and histologic proof of their malignancy. All enrolled subjects should have signed consent for a CTX regimen that is known to be myelotoxic, with counts expected to drop below the absolute neutrophil count (ANC) of 0.5 × 109/L for at least 3 days. These regimens would include at least one of the following:
- Etoposide
- doxorubicin
- ifosfamide
- cyclophosphamide
- ANC and platelet count: Patients must have an ANC \>1 × 109/L and a platelet count \>100 × 109/L to be eligible for therapy at the start of CTX.
- Normal cardiac, renal, and hepatic function.
- All subjects must have a life expectancy of 12 weeks or more.
- Performance Status: Lansky performance score \>60 (age 1 to \<16 years).
- More criteria may apply, please contact the investigator for more information.
- Exclusion:
- Bone marrow involvement.
- Active myelogenous leukemia or history of myelogenous leukemia.
- Previous treatment with colony-stimulating factors (granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor, interleukin 11 \[IL-11\]) less than 6 weeks prior to study entry.
- History of congenital neutropenia or cyclic neutropenia.
- Pregnant or nursing female patients.
- Fertile patients who do not agree to use highly reliable contraceptive measures Prior bone marrow or stem cell transplant, or prior radiation to ≥25% of bone marrow within the 4 weeks prior to the first tbo-filgrastim dose.
- Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit.
- Treatment with lithium at screening or planned during the study
- More criteria may apply, please contact the investigator for more information.
Exclusion
Key Trial Info
Start Date :
May 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02190721
Start Date
May 12 2015
End Date
April 4 2017
Last Update
December 10 2021
Active Locations (33)
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1
Teva Investigational Site 12958
Long Beach, California, United States, 90806
2
Teva Investigational Site 12951
Los Angeles, California, United States, 90024
3
Teva Investigational Site 12954
Jackson, Mississippi, United States, 39216
4
Teva Investigational Site 12953
Las Vegas, Nevada, United States, 89109