Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer
NCT ID: NCT04187898
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2020-03-11
2024-08-16
Brief Summary
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Detailed Description
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The study will be conducted in two phases: Early Phase and Expansion Phase.
1. 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).
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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Early Phase: Eflapegrastim @ 30mins post TC
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.
Eflapegrastim
Administered in Cycle 1, 30 minutes after TC chemotherapy.
Administered in Cycles 2-4, on day 2 of each cycle.
Docetaxel
75 mg/m\^2 IV infusion.
Administered on Day 1 of each cycle.
Cyclophosphamide
600 mg/m\^2 IV infusion.
Administered on Day 1 of each cycle.
Early Phase: Eflapegrastim @ 3 hours post TC
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.
Eflapegrastim
Administered in Cycle 1, 3 hours after TC chemotherapy.
Administered in Cycles 2-4, on day 2 of each cycle.
Docetaxel
75 mg/m\^2 IV infusion.
Administered on Day 1 of each cycle.
Cyclophosphamide
600 mg/m\^2 IV infusion.
Administered on Day 1 of each cycle.
Early Phase: Eflapegrastim @ 5 hours post TC
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.
Eflapegrastim
Administered in Cycle 1, 5 hours after TC chemotherapy.
Administered in Cycles 2-4, on day 2 of each cycle.
Docetaxel
75 mg/m\^2 IV infusion.
Administered on Day 1 of each cycle.
Cyclophosphamide
600 mg/m\^2 IV infusion.
Administered on Day 1 of each cycle.
Expansion Phase: Eflapegrastim @ 30 mins post TC
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.
Eflapegrastim
Administered in Cycles 1-4, 30 mins after TC chemotherapy.
Docetaxel
75 mg/m\^2 IV infusion.
Administered on Day 1 of each cycle.
Cyclophosphamide
600 mg/m\^2 IV infusion.
Administered on Day 1 of each cycle.
Interventions
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Eflapegrastim
Administered in Cycle 1, 30 minutes after TC chemotherapy.
Administered in Cycles 2-4, on day 2 of each cycle.
Eflapegrastim
Administered in Cycle 1, 3 hours after TC chemotherapy.
Administered in Cycles 2-4, on day 2 of each cycle.
Eflapegrastim
Administered in Cycle 1, 5 hours after TC chemotherapy.
Administered in Cycles 2-4, on day 2 of each cycle.
Eflapegrastim
Administered in Cycles 1-4, 30 mins after TC chemotherapy.
Docetaxel
75 mg/m\^2 IV infusion.
Administered on Day 1 of each cycle.
Cyclophosphamide
600 mg/m\^2 IV infusion.
Administered on Day 1 of each cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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SPI-GCF-104
Identifier Type: -
Identifier Source: org_study_id
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