An Analysis to Estimate Febrile Neutropenia (FN) in Patients Receiving Udenyca
Status unconfirmed
Conditions studied: Febrile Neutropenia, Non-myeloid Malignancy
In brief
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 febrile neutropenia (FN).
Key facts
- Study ID
- NCT04662892
- Run by
- Coherus Oncology, Inc.
- People needed
- 200
- Starts
- 2020-08-01
- Expected to finish
- 2022-12-15
- Last updated by the study team
- 2020-12-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Southern Oncology Specialists — Charlotte, North Carolina, United States (enrolling)
- Coastal Cancer Center — Myrtle Beach, South Carolina, United States (enrolling)
- Carolina Blood and Cancer Care, PA — Rock Hill, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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