NCT04187898View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

March 11, 2020

Primary Completion Date

July 16, 2024

Study Completion Date

August 16, 2024

Conditions
NeutropeniaBreast Cancer
Interventions
BIOLOGICAL

Eflapegrastim

"Administered in Cycle 1, 30 minutes after TC chemotherapy.~Administered in Cycles 2-4, on day 2 of each cycle."

BIOLOGICAL

Eflapegrastim

"Administered in Cycle 1, 3 hours after TC chemotherapy.~Administered in Cycles 2-4, on day 2 of each cycle."

BIOLOGICAL

Eflapegrastim

"Administered in Cycle 1, 5 hours after TC chemotherapy.~Administered in Cycles 2-4, on day 2 of each cycle."

BIOLOGICAL

Eflapegrastim

Administered in Cycles 1-4, 30 mins after TC chemotherapy.

DRUG

Docetaxel

"75 mg/m\^2 IV infusion.~Administered on Day 1 of each cycle."

DRUG

Cyclophosphamide

"600 mg/m\^2 IV infusion.~Administered on Day 1 of each cycle."

Trial Locations (8)

33322

BRCR Medical Center, Inc., Plantation

33881

Bond & Steele Clinic, P.A., Winter Haven

44501

Mercy Health Youngstown, Youngstown

59102

SCL Health Research Institute, Inc., Billings

85364

Yuma Regional Medical Center Cancer Center, Yuma

85715

ACRC/ Arizona Clinical Research Center, Tucson

90813

City of Hope, Long Beach

92801

Pacific Cancer Medical Center, Anaheim

All Listed Sponsors
lead

Spectrum Pharmaceuticals, Inc

INDUSTRY

NCT04187898 - Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer | Biotech Hunter | Biotech Hunter