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

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Spectrum Pharmaceuticals

Status and phase

Enrolling
Phase 1

Conditions

Breast Cancer
Neutropenia

Treatments

Drug: Docetaxel
Biological: Eflapegrastim
Drug: Cyclophosphamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04187898
SPI-GCF-104

Details and patient eligibility

About

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.

Full description

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. The study will be conducted in two phases: Early Phase and Expansion Phase. In the Early Phase, approximately 45 patients were enrolled and randomized in a 1:1:1 ratio to 3 dosing time schedule arms. Each cycle was of 21 days. Total 4 cycles were evaluated for this phase. On Day 1 of Cycle 1, patients received Docetaxel and Cyclophosphamide (TC) chemotherapy followed by administration of Eflapegrastim at 1 of 3-time schedules post-TC (30 minutes [mins], 3 hours or 5 hours). During Cycles 2-4, patients received Eflapegrastim 24 hours after TC administration (on Day 2). In the Expansion Phase, additional 45 patients will be enrolled in Cycles 1-4, who will receive fixed dose of Eflapegrastim 30 mins after TC administration (on Day 1). Safety evaluations will be conducted once the first 3 patients (for Early Phase) and the first 6 patients (for Expansion Phase) have completed Cycle 1 to determine if it is safe for patients to continue in that particular treatment arm.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

50 participants in 4 patient groups

Early Phase: Eflapegrastim @ 30mins post TC
Experimental group
Description:
Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg granulocyte colony-stimulating factor [G-CSF]). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 30 minutes from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days.
Treatment:
Drug: Cyclophosphamide
Biological: Eflapegrastim
Drug: Docetaxel
Early Phase: Eflapegrastim @ 3 hours post TC
Experimental group
Description:
Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 3 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days.
Treatment:
Drug: Cyclophosphamide
Biological: Eflapegrastim
Drug: Docetaxel
Early Phase: Eflapegrastim @ 5 hours post TC
Experimental group
Description:
Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycle 1: Administered on the same day as TC chemotherapy, 5 hours from the end of TC administration. Cycles 2-4: Administered 24 hours after TC chemotherapy administration. Each cycle is 21 days.
Treatment:
Drug: Cyclophosphamide
Biological: Eflapegrastim
Drug: Docetaxel
Expansion Phase: Eflapegrastim @ 30 mins post TC
Experimental group
Description:
Eflapegrastim (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF). Supplied in prefilled single-use syringes for subcutaneous injection. Cycles 1-4: Administered on the same day as TC chemotherapy, 30 minutes following the end of TC administration. Each cycle is 21 days.
Treatment:
Drug: Cyclophosphamide
Biological: Eflapegrastim
Drug: Docetaxel

Trial contacts and locations

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Central trial contact

Howard Franklin, MD

Data sourced from clinicaltrials.gov

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