NCT04570423 A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
| NCT ID | NCT04570423 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Spectrum Pharmaceuticals, Inc |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-05-20 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2021-05-20 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Participant must have a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement. 2. Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines. 3. Participant has adequate hematological, renal, and hepatic function. 4. Participant must have an echocardiogram (ECHO) or multigated acquisition (MUGA) within 14 days of Screening if receiving a cardiotoxic therapy and have a cardiac ejection fraction of \>50%. 5. Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry. 6. Participant has a Karnofsky performance level ≥50% for patients ≥16 years of age or a Lansky performance level ≥50 for children \<16 years of age. Exclusion Criteria: 1. Participant has an uncontrollable infection, has an underlying medical condition, and/or another serious illness that would impair the ability of the participant to receive protocol-specified treatment. 2. Participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor (G-CSF) products in clinical development within 2 weeks prior to the administration of study drug (eflapegrastim) 3. Participant requires concurrent radiation therapy specifically in Cycle 1. 4. Participant has had prior bone marrow or hematopoietic stem cell transplant and/or has concurrent bone marrow involvement in their malignancy, including leukemia. 5. Participant has had spinal radiation therapy within 30 days prior to study enrollment. 6. Participant has used any investigational drugs, biologics or devices within 30 days prior to study treatment or plans to use any of these during the study. 7. Participant has a known sensitivity or previous reactions to any of the G-CSF products. 8. Participant with active CNS disease. 9. Participant has not recovered from previous treatment adverse events to ≤Grade 1.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04570423 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 17 Years, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04570423 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04570423 currently recruiting?
Yes, NCT04570423 is actively recruiting participants. Contact the research team at Hfranklin@assertiotx.com for enrollment information.
Where is the NCT04570423 trial being conducted?
This trial is being conducted at Valhalla, United States, Charlotte, United States, Charlotte, United States, Cleveland, United States and 1 additional location.
Who is sponsoring the NCT04570423 clinical trial?
NCT04570423 is sponsored by Spectrum Pharmaceuticals, Inc. The trial plans to enroll 40 participants.