A clinical study to assess the safety and effectiveness of tbo-filgrastim in infants,children and adolescents with solid tumors without bone marrow involvement

Phase 1

• Conditions: Chemotherapy induced Neutropenia; MedDRA version: 19.0Level: HLTClassification code 10029355Term: NeutropeniasSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001772-55-HR
• Lead Sponsor: TEVA Pharmaceutical Industries Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-26
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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:
Etoposide
doxorubicin
ifosfamide
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

Exclusion Criteria

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.Pregnant or nursing female patients.
h. Do not agree to use adequate contraceptive.
i. 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.
j. Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit.
k. Treatment with lithium at screening or planned during the study.
l. Participation in an interventional clinical study within 30 days or 5 half-lives of the investigational product before enrollment, whichever is longer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified