A Phase 1 interventional study of Eflapegrastim and Eflapegrastim in Neutropenia and Breast Cancer, sponsored by Spectrum Pharmaceuticals, Inc. Completed at 8 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Spectrum Pharmaceuticals, Inc (part of Zydus Lifesciences Limited) · Phase 1, Interventional, and Treatment
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.
The study will be conducted in two phases: Early Phase and Expansion Phase.
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.
405 studies on the registry are indexed under Neutropenia; 60 are open to participants now.
This study's enrollment of 59 is below the median of 93 across 285 interventional studies indexed under Neutropenia.
Browse Neutropenia studies →Spectrum Pharmaceuticals, Inc is the lead sponsor of 60 studies on the registry; 1 is open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 12 (67%) have results posted.
First submitted before Spectrum Pharmaceuticals, Inc became part of Zydus Lifesciences Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Biological: Eflapegrastim · Drug: Docetaxel · Drug: Cyclophosphamide
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.
Biological: Eflapegrastim · Drug: Docetaxel · Drug: Cyclophosphamide
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.
Biological: Eflapegrastim · Drug: Docetaxel · Drug: Cyclophosphamide
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.
Biological: Eflapegrastim · Drug: Docetaxel · Drug: Cyclophosphamide
Administered in Cycle 1, 30 minutes after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle.
Administered in Cycle 1, 3 hours after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle.
Administered in Cycle 1, 5 hours after TC chemotherapy. Administered in Cycles 2-4, on day 2 of each cycle.
Administered in Cycles 1-4, 30 mins after TC chemotherapy.
75 mg/m\^2 IV infusion. Administered on Day 1 of each cycle.
Also known as: Taxotere
600 mg/m\^2 IV infusion. Administered on Day 1 of each cycle.
Also known as: Cytoxan
Time to Recovery of Absolute Neutrophil Count (ANC) From Nadir to ≥1.5×10^9/L in Cycle 1
Time to ANC Recovery is defined as the time from chemotherapy administration until the patient's ANC increases to ≥1.5×10\^9/liter (L) after the expected nadir.
Time frame: Cycle 1 is 21 days
Duration of Grade 4 Neutropenia (DSN) in Cycle 1
DSN is defined as the number of days of severe neutropenia where the ANC\<0.5x10\^9/L from the first occurrence of an ANC below the threshold.
Time frame: Cycle 1 is 21 days
Proportion of Patients With Grade 4 Neutropenia in Cycle 1
Time frame: Cycle 1 is 21 days
Incidence of Grade 3 Febrile Neutropenia (FN) in Cycle 1
FN is defined as having an ANC\<1.0x10\^9/L and either a single temperature of \>38.3 degrees Celsius (101.0 Fahrenheit \[F\]) or a sustained temperature of \>38.0 degrees Celsius (100.4 F).
Time frame: Cycle 1 is 21 days
Incidence of Neutropenic Complications, Including Hospitalization due to Neutropenia, FN, and use of Anti-infectives During Cycle 1
Time frame: Cycle 1 is 21 days
Expansion Phase: Time to Recovery of ANC From Nadir to ≥1.5×10^9/L in Cycles 2-4
Time to ANC Recovery is defined as the time from chemotherapy administration until the patient's ANC increases to ≥1.5×10\^9/L after the expected nadir.
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: DSN in Cycles 2-4
DSN is defined as the number of days of severe neutropenia where the ANC \<0.5x10\^9/L from the first occurrence of an ANC below the threshold.
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Proportion of Patients With Grade 4 Neutropenia in Cycles 2-4
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Incidence of FN in Cycles 2-4
FN is defined as having an ANC\<1.0x10\^9/L and either a single temperature of \>38.3 degrees Celsius (101.0 F) or a sustained temperature of \>38.0 degrees Celsius (100.4 F).
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Expansion Phase: Incidence of Neutropenic Complications, Including Hospitalization due to Neutropenia, FN, and use of Anti-infectives During Cycles 2-4
Time frame: Cycles 2-4 (cycle length=21 days) (up to approximately 63 days)
Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety
Time frame: Up to approximately 40 days after the last dose of study treatment or early study discontinuation (up to approximately 4 months)
Proportion of Patients Discontinuing Because of a TEAE
Time frame: Up to approximately 40 days after the last dose of study treatment or early study discontinuation (up to approximately 4 months)
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Eflapegrastim · Docetaxel · Cyclophosphamide
Spectrum Pharmaceuticals, Inc →