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

  • End date
    Jan 1, 2022
  • participants needed
  • sponsor
    Spectrum Pharmaceuticals, Inc
Updated on 21 November 2020
platelet count
breast cancer
blood draw
breast cancer staging
early-stage breast cancer


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.


This is a Phase 1, randomized, open label, actively-controlled study to evaluate the same day dosing of Eflapegrastim on duration of neutropenia when administered at varying intervals following Docetaxel and Cyclophosphamide (TC) chemotherapy in patients with early-stage breast cancer .

Approximately 45 patients will be enrolled and randomized in a 1:1:1 ratio to 3 dosing time schedule arms.

Each cycle will be 21 days. Total 4 cycles will be evaluated for this study. On Day 1 of Cycle 1, patients will receive Docetaxel and Cyclophosphamide (TC)chemotherapy followed by administration of Eflapegrastim at 1 of 3 time schedules post-TC (30mins, 3 hours or 5 hours). During Cycles 2-4, patients will receive Eflapegrastim 24 hours after TC administration (on Day 2).

Safety evaluations will be conducted once the first 3 patients in each arm have completed Cycle 1 to determine if it is safe for patients to continue in that particular treatment arm.

Treatment cyclophosphamide, docetaxel, Eflapegrastim
Clinical Study IdentifierNCT04187898
SponsorSpectrum Pharmaceuticals, Inc
Last Modified on21 November 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Neutropenia or Breast Cancer?
Do you have any of these conditions: Leukopenia or Breast Cancer or breast carcinoma or cancer, breast or Neutropenia or Breast Cancer Diagnosis?
Do you have any of these conditions: Breast Cancer Diagnosis or cancer, breast or Leukopenia or Neutropenia or Breast Cancer or breast carcinoma?
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
ANC 1.510^9/L
Platelet count 10010^9/L
Hemoglobin >10 g/dL
Calculated creatinine clearance > 50 mL/min
Total bilirubin 1.5 mg/dL
AST/SGOT and ALT/SGPT 2.5ULN. (upper limit of normal)
Alkaline phosphatase 2.0ULN
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

Exclusion Criteria

Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
Known sensitivity to 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
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