Status:
UNKNOWN
An Analysis to Estimate Febrile Neutropenia (FN) in Patients Receiving Udenyca
Lead Sponsor:
Coherus Oncology, Inc.
Collaborating Sponsors:
Community Clinical Oncology Research Network, LLC
Conditions:
Febrile Neutropenia
Non-myeloid Malignancy
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter, prospective, observational cohort registry in subjects receiving myelosuppressive chemotherapy for a non-myeloid malignancy who are considered to be at high risk for developing ...
Detailed Description
Little is known about the real-world risk of febrile neutropenia (FN) among subjects receiving Udenyca. Udenyca was approved due to the totality of evidence under the new Food and Drug Administration ...
Eligibility Criteria
Inclusion
- Subject ≥ 18 years of age at the time of signing the informed consent form.
- Subject has biopsy-proven malignancy and is starting myelosuppressive chemotherapy in the neoadjuvant/adjuvant or first line advanced/metastatic setting with at least 4 anticipated chemotherapy cycles.
- Subject's life expectancy \> 6 months.
- Subject is in a high-risk category for FN: 1) the subject is starting or has, within the past 7 days, started a myelosuppressive chemotherapy regimen with a high (\> 20%) FN risk 2) patient is on a chemotherapy regimen with an intermediate (10-20%) FN risk but is determined by his or her treating physician to be at a high-risk (therefore requiring primary prophylaxis with myeloid growth factor), or 3) patient is on secondary prophylaxis for FN (per NCCN guidelines).
- Subject is starting adjuvant chemotherapy, neoadjuvant chemotherapy, or first line chemotherapy in the metastatic setting and will be receiving at least 4 cycles of planned chemotherapy.
- Subjects already receiving any other Pegfilgrastim (switching) as a FN prophylaxis will be allowed to enroll so long as they have at least two cycles left in their planned treatment.
Exclusion
- Subject initiating chemotherapy regiment wtih \<14 days between cytotoxic and G-CSF drug dosing.
- Planned chemotherapy dose reduction for cycle 1.
- Known history of serious allergic reactions to Pegfilgrastim or Filgrastim.
- Contraindication to short acting G-CSFs, Pegfilgrastim biosimilar PFS
- Currently receiving treatment in another investigational device or drug study, or
- ≤ 28 days before screening/enrollment since ending treatment on another investigational device or drug study.
- Subject who has received radiation \< 2 weeks prior to study enrollment.
- Any co-morbidity in the opinion of the investigator that will prevent the subject from receiving chemotherapy.
- Subject has significant abnormalities on the most recent laboratory test prior to Screening/Enrollment per the Investigator including but not limited to the following:
- white blood cell (WBC) \< 4, ANC \< lower limit of normal (LLN), hemoglobin \< 10 g/dL, hematocrit \< 30%, platelet count \< 100,000, creatinine ≥ 1.5 or glomerular filtration rate \< 30 (as calculated by Cockcroft-Gault Equation), total bilirubin ≥ 2.0, aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≥ 3 x upper limit of normal (ULN), subject without liver metastasis or AST/ALT ≥ 5 ULN in a subject with liver metastasis
- Known human immunodeficiency virus (HIV) infection by history.
- History of solid organ or stem cell transplant.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 15 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04662892
Start Date
August 1 2020
End Date
December 15 2022
Last Update
December 23 2020
Active Locations (3)
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1
Southern Oncology Specialists
Charlotte, North Carolina, United States, 10320
2
Coastal Cancer Center
Myrtle Beach, South Carolina, United States, 29572
3
Carolina Blood and Cancer Care, PA
Rock Hill, South Carolina, United States, 29732