A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Efficacy, and Immunogenicity of Daily Subcutaneous Administration of 5 µg/kg tbo-filgrastim in Infants, Children and Adolescents with Solid Tumors without Bone Marrow Involvement

TEVA Pharmaceutical Industries Ltd0 个研究点目标入组 50 人开始时间: 2015年2月4日最近更新: 2018年6月5日

适应症

试验速览

暂无简介。

•Patients may be included in the study only if they meet all of the following criteria:
•a. Male or female infants, children and adolescents aged 1 month to <16 years.
•b. Patients with solid tumors without bone marrow involvement (ie, non-myeloid neoplasms), who are scheduled to receive myelosuppressive CTX.
•c. Body weight =5 kg.
•d. Written informed consent provided by parent(s)/legal representative(s)
•e. Patients must have an initial diagnosis and histologic proof of their malignancy, recurrence of their disease, clear radiographic or biopsy evidence is required within 4 weeks prior to study entry.
•f. All enrolled subjects should have signed consent for a CTX regimen that is known to be myelotoxic, with counts expected to drop below the ANC of 0.5 × 109/L for at least 3 days. These regimens would include at least 1 of the following:
•doxorubicin
•cyclophosphamide
•g. Patients must have an ANC >1 × 109/L and a platelet count >100 × 109/L at the start of CTX.
•h. Normal cardiac, renal, and hepatic function.
•i. All subjects must have a life expectancy of 12 weeks or more.
•j. Performance Status: Lansky performance score >60 (age 1 to <16 years).
•k. Adequate contraceptive use.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 50
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients will be excluded from participating in this study if they meet any of the following criteria:
•a. Bone marrow involvement.
•b. Active myelogenous leukemia or history of myelogenous leukemia.
•c. Previous treatment with colony-stimulating factors (G-CSF, granulocyte-macrophage
•colony-stimulating factor, Interleukin 11 [IL-11]) less than 6 weeks prior to study entry.
•d. Known hypersensitivity to any component of this product.
•e. History of congenital neutropenia or cyclic neutropenia.
•f. Any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint.
•g. Agree to use adequate contraceptive.
•h. 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.
•i. Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit.
•j. Treatment with lithium at screening or planned during the study.
•k. Participation in an interventional clinical study within 30 days or 5 half-lives of the investigational product before enrollment, whichever is longer.

发起方

TEVA Pharmaceutical Industries Ltd