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

NCT03135951 | Completed Phase 1 FDA Drug

• 1 other identifier: SPI-GCF-301-PK
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Pharmacokinetics

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  PK samples will be collected at predetermined time intervals and Peak Concentration is measured at highest value among all concentrations.

  Up to 42 days

• Area under the plasma concentration versus time curve (AUC)

  PK samples will be collected at predetermined time intervals. AUC is calculated in the plot of plasma concentration versus time curve

  Up to 42 days

Secondary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

  6 months

• Population slope of the relationship between the change from baseline in QTc intervals and plasma concentrations of SPI-2012

  Up to 42 days

Study Arms (1)

SPI-2012

EXPERIMENTAL

* 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

Drug: SPI-2012

Interventions

SPI-2012 DRUG

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

Also known as: Rolontis™, Eflapegrastim

SPI-2012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (1)

Research Center

Anaheim, California, 92804, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eflapegrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shanta Chawla, MD

  Spectrum Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 2, 2017
• Study Start: May 11, 2017
• Primary Completion: February 19, 2018
• Study Completion: May 18, 2018
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (1)