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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Treatments: Cyclophosphamide; Docetaxel

Criteria

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

• ANC ≥1.5×10^9/L

• Platelet count ≥100×10^9/L.

• Hemoglobin >10 g/dL.

• Calculated creatinine clearance > 50 mL/min.

• Total bilirubin ≤1.5 mg/dL.

• AST/SGOT and ALT/SGPT ≤2.5×ULN. (upper limit of normal)

• Alkaline phosphatase ≤2.0×ULN.

• 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 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