Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer

Completed · Phase 1

Conditions studied: Neutropenia, Breast Cancer

In brief

The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration.

Key facts

Study ID

NCT04187898

Run by

Spectrum Pharmaceuticals, Inc

People needed

59

Starts

2020-03-11

Expected to finish

2024-08-16

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and capable of giving written Informed Consent and able to adhere to study drug dosing time and blood draw schedules
• New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
• Candidate to receive adjuvant or neoadjuvant TC chemotherapy
• Age must be at least 18 years for the Early Phase, and between 18 to ≤55 years for the Expansion Phase
• ANC ≥1.5×10\^9/liter (L).
• Platelet count ≥100×10\^9/liter (L).
• Hemoglobin >10 grams per deciliter (g/dL).
• Calculated creatinine clearance >50 milliliter per minute (mL/min).
• Total bilirubin ≤1.5 milligrams per deciliter (mg/dL).
• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤2.5×upper limit of normal (ULN).
• Alkaline phosphatase ≤2.0×ULN.
• Eastern Cooperative Oncology Group (ECOG) ≤2
• Willing to practice 2 forms of contraceptives (1 must be a barrier method), from study entry through 30 days after last dose of study drug/ early discontinuation
• Negative urine pregnancy test within 30 days before randomization

You may not qualify if…

• Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
• Known sensitivity to Escherichia coli (E. coli) derived products
• Concurrent adjuvant cancer therapy other than the trial-specified therapies
• Locally recurrent/metastatic breast cancer
• Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 3 months prior to the administration of study drug
• Receiving anti-infectives, has an underlying medical condition or other serious illness that would impair the ability to receive protocol-specified treatment
• Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study
• Prior bone marrow or stem cell transplant
• Prior radiation therapy within 30 days prior to enrollment
• Major surgery within 30 days prior to enrollment
• Pregnant or breastfeeding

Where it is running

• ACRC/ Arizona Clinical Research Center — Tucson, Arizona, United States
• Yuma Regional Medical Center Cancer Center — Yuma, Arizona, United States
• Pacific Cancer Medical Center — Anaheim, California, United States
• City of Hope — Long Beach, California, United States
• BRCR Medical Center, Inc. — Plantation, Florida, United States
• Bond & Steele Clinic, P.A. — Winter Haven, Florida, United States
• SCL Health Research Institute, Inc. — Billings, Montana, United States
• Mercy Health Youngstown — Youngstown, Ohio, United States

Full record on ClinicalTrials.gov

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