Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04570423 | RECRUITING | Solid Tumors

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

Spectrum Pharmaceuticals, Inc

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.

Condition or disease

Solid Tumors

Lymphoma

Intervention/treatment

Eflapegrastim

Chemotherapy

Phase

PHASE2

Detailed Description:

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
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
Actual Study Start Date : 2021-05-20
Estimated Primary Completion Date : 2027-10
Estimated Study Completion Date : 2027-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Month to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy

Location Details

NCT04570423

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

New York Medical College

Valhalla, New York, United States, 10595

RECRUITING

United States, North Carolina

Carolinas Medical Center/ Levine Children's Hospital

Charlotte, North Carolina, United States, 28203

RECRUITING

United States, North Carolina

Levine Children's Health

Charlotte, North Carolina, United States, 28203

RECRUITING

United States, Texas

UT MD Anderson Cancer Center

Houston, Texas, United States, 77030