Spots Global Cancer Trial Database for A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
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Trial Identification
Brief Title: A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
Official Title: A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Efficacy, and Immunogenicity of Daily Subcutaneous Administration of 5 ?g/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
Study ID: NCT02190721
Conditions
Interventions
Study Description
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 with solid tumors without bone marrow involvement.
Detailed Description:
Keywords
Eligibility
Minimum Age: 1 Month
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Teva Investigational Site 12958, Long Beach, California, United States
Teva Investigational Site 12951, Los Angeles, California, United States
Teva Investigational Site 12954, Jackson, Mississippi, United States
Teva Investigational Site 12953, Las Vegas, Nevada, United States
Teva Investigational Site 12959, Valhalla, New York, United States
Teva Investigational Site 12960, Columbus, Ohio, United States
Teva Investigational Site 12957, Houston, Texas, United States
Teva Investigational Site 59104, Sofia, , Bulgaria
Teva Investigational Site 59105, Varna, , Bulgaria
Teva Investigational Site 60015, Rijeka, , Croatia
Teva Investigational Site 60014, Zagreb, , Croatia
Teva Investigational Site 60016, Zagreb, , Croatia
Teva Investigational Site 51186, Budapest, , Hungary
Teva Investigational Site 51185, Budapest, , Hungary
Teva Investigational Site 51184, Szeged, , Hungary
Teva Investigational Site 53249, Gdansk, , Poland
Teva Investigational Site 53248, Lublin, , Poland
Teva Investigational Site 53245, Warszawa, , Poland
Teva Investigational Site 53246, Warszawa, , Poland
Teva Investigational Site 53247, Wroclaw, , Poland
Teva Investigational Site 52063, Bucharest, , Romania
Teva Investigational Site 52064, Cluj-Napoca, Cluj, , Romania
Teva Investigational Site 52065, Timisoara, , Romania
Teva Investigational Site 50282, Chelyabinsk, , Russian Federation
Teva Investigational Site 50281, Krasnodar, , Russian Federation
Teva Investigational Site 50284, Moscow, , Russian Federation
Teva Investigational Site 50280, St. Petersburg, , Russian Federation
Teva Investigational Site 50283, Volgograd, , Russian Federation
Teva Investigational Site 58147, Kharkiv, , Ukraine
Teva Investigational Site 58145, Kyiv, , Ukraine
Teva Investigational Site 58148, Lviv, , Ukraine
Teva Investigational Site 58146, Vinnytsya, , Ukraine
Teva Investigational Site 58149, Vinnytsya, , Ukraine
Contact Details
Name: Teva Medical Expert, MD
Affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
Role: STUDY_DIRECTOR
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