Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy

NCT ID: NCT03135951

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-11
• Study Completion Date: 2018-05-18

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration.

Detailed Description

This is a Phase 1, single-arm multicenter study to evaluate the PK and safety of SPI-2012 (a long acting myeloid growth factor) in breast cancer patients treated with TC chemotherapy.

Approximately 25 patients will be enrolled.

Each cycle will be 21 days and patients will receive 4 cycles of treatment with 2 additional cycles based on the investigator's discretion. On Day 1 of each cycle, patients will receive TC chemotherapy and on Day 2 of each cycle, patients will receive SPI-2012.

Pharmacokinetics will be evaluated only in Cycles 1 and 3.

Conditions

Breast Cancer; Pharmacokinetics

Keywords

Breast Cancer; Pharmacokinetics; Long-acting Myeloid Growth Factor; Early Stage Breast Cancer; Docetaxel + Cyclophosphamide (TC) Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SPI-2012

• SPI-2012 (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF per cycle)
• Supplied in 1 mL prefilled, single-use syringes for subcutaneous injection
• Administered on Day 2 of each cycle after TC administration

Group Type: EXPERIMENTAL

SPI-2012

Intervention Type: DRUG

Supplied in prefilled, single-use syringes for subcutaneous injection and administered on Day 2 of each cycle.

Interventions

SPI-2012

Supplied in prefilled, single-use syringes for subcutaneous injection and administered on Day 2 of each cycle.

Intervention Type: DRUG

Other Intervention Names

Rolontis™; Eflapegrastim

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed, histologically confirmed early-stage breast cancer, defined as operable Stage I to Stage IIIA breast cancer.
• Candidate to receive adjuvant or neoadjuvant TC chemotherapy.
• ANC ≥1.5x10^9/L
• Platelet count ≥100x10^9/L
• Hemoglobin >9 g/dL
• Calculated creatinine clearance >50 mL/min
• Total bilirubin ≤1.5 mg/dL
• AST and ALT ≤2.5xULN
• Alkaline phosphatase ≤2.0xULN
• ECOG ≤2

Exclusion Criteria

• Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of cervix) or life-threatening disease. If history of prior malignancies or contralateral breast cancer, must be disease free for at least 5 years.
• Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing.
• Concurrent adjuvant cancer therapy.
• Locally recurrent/metastatic breast cancer.
• Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug.
• Active infection, receiving antibiotics or any serious underlying medical condition which would impair the ability of the patient to receive protocol-specified treatment.
• Prior bone marrow or hematopoietic stem cell transplant
• 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 radiation therapy within 30 days prior to enrollment.
• Major surgery within 30 days prior to enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shanta Chawla, MD

Role: STUDY_DIRECTOR

Spectrum Pharmaceuticals, Inc

Locations

Research Center

Anaheim, California, United States

Countries

United States

Other Identifiers

SPI-GCF-301-PK

Identifier Type: -

Identifier Source: org_study_id