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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04570423
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Solid Tumors Lymphoma Drug: Eflapegrastim Drug: Chemotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 : May 20, 2021
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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).
Drug: Eflapegrastim
Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
Other Names:
  • Rolontis®
  • SPI-2012

Drug: Chemotherapy
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.

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).
Drug: Eflapegrastim
Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
Other Names:
  • Rolontis®
  • SPI-2012

Drug: Chemotherapy
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.

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).
Drug: Eflapegrastim
Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
Other Names:
  • Rolontis®
  • SPI-2012

Drug: Chemotherapy
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.

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).
Drug: Eflapegrastim
Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
Other Names:
  • Rolontis®
  • SPI-2012

Drug: Chemotherapy
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.




Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With Severe Neutropenia in Cycle 1 [ Time Frame: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected) ]
    Severe neutropenia is defined as absolute neutrophil count (ANC) less than 0.5*10^9/liter (L).

  2. Time to Absolute Neutrophil Count (ANC) Recovery of Severe Neutropenia in Cycle 1 [ 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 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.

  3. Number of Participants With Febrile Neutropenia in Cycle 1 [ Time Frame: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected) ]
    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.

  4. 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) ]
  5. Time 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) ]
  6. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570423


Contacts
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Contact: Shanta Chawla, MD 949-788-6700 SPI-GCF-202@sppirx.com
Contact: Helen Vu 949-788-6700

Locations
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United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
Carolinas Medical Center/ Levine Children's Hospital Recruiting
Charlotte, North Carolina, United States, 28203
Levine Children's Health Recruiting
Charlotte, North Carolina, United States, 28203
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT04570423    
Other Study ID Numbers: SPI-GCF-202
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spectrum Pharmaceuticals, Inc:
Lymphomas
Solid Tumors
Chemotherapy
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases