The purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.
This is a Phase 2, open label, multicenter study of eflapegrastim in pediatric participants (≥1 month to \<17 years) with solid tumors or lymphoma. Approximately 40 participants will be enrolled and assigned to one of 4 age-based cohorts. Participants enrolled in Cohort 1 will be followed for dose-limiting toxicities (DLTs) prior to initiating parallel enrollment into Cohorts 2 through 4. All participants will receive chemotherapy as Standard of Care after which a subcutaneous (SC) dose of eflapegrastim will be administered up to 4 treatment cycles.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
Chemotherapy agents may include doxorubicin, ifosfamide, docetaxel, CHOP regimen, etoposide, cyclophosphamide and vincristine which will be administered as per standard of care per the Primary Care physician's treatment plan.
New York Medical College
Valhalla, New York, United States
TERMINATEDCarolinas Medical Center/ Levine Children's Hospital
Charlotte, North Carolina, United States
TERMINATEDLevine Children's Health
Charlotte, North Carolina, United States
TERMINATEDNumber of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is any AE that occurs from the first dose of the study drug until 35 days after the last dose of study drug, or on the day a new/additional chemotherapy regimen, or on the day another granulocyte-colony stimulating factor (G-CSF) is administered.
Time frame: From first dose of study drug to 35 days after the last dose of the study drug (Up to approximately 16 months)
Percentage of Participants With Severe Neutropenia in Cycle 1
Severe neutropenia is defined as absolute neutrophil count (ANC) less than 0.5\*10\^9/liter (L).
Time frame: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
Time to Absolute Neutrophil Count (ANC) Recovery of Severe Neutropenia in Cycle 1
Time to ANC recovery of severe neutropenia is defined as the time from chemotherapy administration until the participants ANC increases to ≥1.0\*10\^9/L after the expected nadir.
Time frame: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
Number of Participants With Febrile Neutropenia in Cycle 1
Febrile neutropenia is defined as ANC less than 0.5\*10\^9/L with a single temperature of \>38.3 degree Celsius (°C) or a sustained temperature of ≥38°C for more than 1 hour.
Time frame: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
Peak Concentration (Cmax) of Eflapegrastim in Cycle 1
Time frame: Pre-dose and at multiple time points (up to Day 9 [Cohorts 1-3] and Day 6 [Cohort 4]) post-dose in Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGUT MD Anderson Cancer Center
Houston, Texas, United States
TERMINATEDTime to Reach Peak Concentration (Tmax) of Eflapegrastim in Cycle 1
Time frame: Pre-dose and at multiple time points (up to Day 9 [Cohorts 1-3] and Day 6 [Cohort 4]) post-dose in Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
Elimination Half-life (t½) of Eflapegrastim in Cycle 1
Time frame: Pre-dose and at multiple time points (up to Day 9 [Cohorts 1-3] and Day 6 [Cohort 4]) post-dose in Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)