Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT04662892
Eligibility Criteria:
Inclusion Criteria:
1. Subject ≥ 18 years of age at the time of signing the informed consent form.
2. 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.
3. Subject's life expectancy \> 6 months.
4. 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).
5. 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.
6. 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 Criteria:
1. Subject initiating chemotherapy regiment wtih \<14 days between cytotoxic and G-CSF drug dosing.
2. Planned chemotherapy dose reduction for cycle 1.
3. Known history of serious allergic reactions to Pegfilgrastim or Filgrastim.
4. Contraindication to short acting G-CSFs, Pegfilgrastim biosimilar PFS
5. 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.
6. Subject who has received radiation \< 2 weeks prior to study enrollment.
7. Any co-morbidity in the opinion of the investigator that will prevent the subject from receiving chemotherapy.
8. 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
9. Known human immunodeficiency virus (HIV) infection by history.
10. History of solid organ or stem cell transplant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04662892
Study Brief:
Protocol Section:
NCT04662892