Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemother… (NCT03559387) | Clinical Trial Compass
TerminatedPhase 2
Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia
Stopped: Study redesign
France, Netherlands9 participantsStarted 2017-08-03
Plain-language summary
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHOâ„¢ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult female patients, 18 years of age or older
✓. Signed and dated written consent/assent by the patient or legally authorized representative
✓. Histologically confirmed non-metastatic breast cancer
✓. ECOG performance status ≤ 2
✓. Myelosuppressive chemotherapy naive
✓. Scheduled to receive and anticipated to complete the following chemotherapy regimen
✕. Known hypersensitivity to E.coli derived products or polyethylene glycol
✕. No other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥ 5 years ago with curative intent
✕. Evidence of myelodysplasia, aplastic anemia, myelofibrosis, rheumatoid arthritis, systemic lupus erythematosus, or sickle cell disease
✕. Clinical diagnosis or history of chronic infection such as hepatitis B virus (HBV), hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or history of tuberculosis
✕
What they're measuring
1
Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the first cycle of chemotherapy (FE100C).