A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy

Part of paid clinical trials in Valhalla, New York.

Sponsor
Spectrum Pharmaceuticals, Inc
Study ID
NCT04570423
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Month - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Eflapegrastim — DRUG
    Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
  • Chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 20, 2021
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: ≥12 to <17 years
    Participants will receive a SC injection of eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected).
  • Experimental: Cohort 2: ≥6 to <12 years
    Participants will receive a SC injection eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected).
  • Experimental: Cohort 3: ≥2 to <6 years
    Participants will receive a SC injection eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected).
  • Experimental: Cohort 4: ≥1 month to <2 years
    Participants will receive a SC injection eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected).

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug to 35 days after the last dose of the study drug (Up to approximately 16 months) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
New York Medical CollegeValhallaNew York10595-
Carolinas Medical Center/ Levine Children's HospitalCharlotteNorth Carolina28203-
Levine Children's HealthCharlotteNorth Carolina28203-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Valhalla, NY

By research site
New York Medical College· Valhalla, NYCarolinas Medical Center/ Levine Children's Hospital· Charlotte, NCLevine Children's Health· Charlotte, NCUniversity Hospitals Cleveland Medical Center· Cleveland, OHUT MD Anderson Cancer Center· Houston, TX

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