An Analysis to Estimate Febrile Neutropenia (FN) in Patients Receiving Udenyca

• Conditions: Febrile Neutropenia; Non-myeloid Malignancy

• Registration Number: NCT04662892
• Lead Sponsor: Coherus Biosciences, Inc.

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 febrile neutropenia (FN).

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 (FDA) pathway 351 (k), which met all the endpoints of pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity in healthy volunteers. Udenyca is the only p...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-08-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-23
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of FN in real-world outcome setting	24 months	Calculation of the incidence of FN (as defined by NCCN) among subjects in a real-world outcome setting who are 1) being treated with myelosuppressive chemotherapy for the treatment of non- myeloid malignancies and 2) receiving Udenyca with every administered chemotherapy cycle for FN prophylaxis.

Secondary Outcome Measures

Name	Time	Method
The incidence in FN in a palliative setting	24 months	Calculation of the incidence of FN (as defined by NCCN) among subjects in a palliative setting who are 1) being treated with myelosuppressive chemotherapy for the treatment of non-myeloid malignancies and 2) receiving Udenyca with every administered chemotherapy cycle for FN prophylaxis.
The incidence of FN in a curative setting	24 months	Calculation of the incidence of FN (as defined by NCCN) among subjects in a curative setting who are 1) being treated with myelosuppressive chemotherapy for the treatment of non-myeloid malignancies and 2) receiving Udenyca with every administered chemotherapy cycle for FN prophylaxis
Measure quality of life in subjects receiving Udenyca for FN prophylaxis	24 months	Measurement of HRQoL in subjects who received Udenyca with FN prophylaxis
To compare the incidence of FN in subjects who switched to Udenyca	24 months	To compare the incidence of FN in subject who switched to Udenyca with the estimated incidence of FN in subjects who received other Pegfilgrastims for FN prophylaxis (overall) in curative and palliative settings.

Trial Locations

Locations (3)

Carolina Blood and Cancer Care, PA; 🇺🇸 Rock Hill, South Carolina, United States

Coastal Cancer Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Southern Oncology Specialists; 🇺🇸 Charlotte, North Carolina, United States