A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement

NCT ID: NCT02190721

Last Updated: 2021-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-12
• Study Completion Date: 2017-04-04

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.

Conditions

Neutropenia

Keywords

Neutropenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tbo-filgrastim

Patients will receive subcutaneous doses of tbo-filgrastim 5 μg/kg body weight daily; each daily dose, to be administered at the investigative site

Group Type: EXPERIMENTAL

tbo-filgrastim

Intervention Type: DRUG

5 μg/kg

Interventions

tbo-filgrastim

5 μg/kg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female infants, children and adolescents aged 1 month to <16 years.

2. Patients with solid tumors without bone marrow involvement, who are scheduled to receive myelosuppressive CTX.

3. Body weight ≥5 kg.

4. 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

5. 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.

6. Normal cardiac, renal, and hepatic function.

7. All subjects must have a life expectancy of 12 weeks or more.

8. Performance Status: Lansky performance score >60 (age 1 to <16 years).

• More criteria may apply, please contact the investigator for more information.

Exclusion:

1. Bone marrow involvement.

2. Active myelogenous leukemia or history of myelogenous leukemia.

3. 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.

4. History of congenital neutropenia or cyclic neutropenia.

5. Pregnant or nursing female patients.

6. 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.

7. Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit.

8. Treatment with lithium at screening or planned during the study

• More criteria may apply, please contact the investigator for more information.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

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

Warsaw, , Poland

Teva Investigational Site 53246

Warsaw, , 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

Timișoara, , Romania

Teva Investigational Site 50282

Chelyabinsk, , Russia

Teva Investigational Site 50281

Krasnodar, , Russia

Teva Investigational Site 50284

Moscow, , Russia

Teva Investigational Site 50280

Saint Petersburg, , Russia

Teva Investigational Site 50283

Volgograd, , Russia

Teva Investigational Site 58147

Kharkiv, , Ukraine

Teva Investigational Site 58145

Kyiv, , Ukraine

Teva Investigational Site 58148

Lviv, , Ukraine

Teva Investigational Site 58146

Vinnytsia, , Ukraine

Teva Investigational Site 58149

Vinnytsia, , Ukraine

Countries

Serbia; United States; Bulgaria; Croatia; Hungary; Poland; Romania; Russia; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-001772-55

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

XM02-ONC-201

Identifier Type: -

Identifier Source: org_study_id