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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03135951
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : December 31, 2018
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Pharmacokinetics Drug: SPI-2012 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
Actual Study Start Date : May 11, 2017
Actual Primary Completion Date : February 19, 2018
Actual Study Completion Date : May 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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
Drug: SPI-2012
Supplied in prefilled, single-use syringes for subcutaneous injection and administered on Day 2 of each cycle.
Other Names:
  • Rolontis™
  • Eflapegrastim

Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: Up to 42 days ]
    PK samples will be collected at predetermined time intervals and Peak Concentration is measured at highest value among all concentrations.

  2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to 42 days ]
    PK samples will be collected at predetermined time intervals. AUC is calculated in the plot of plasma concentration versus time curve

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 6 months ]
    An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A treatment-emergent AE (TEAE) is any AE that occurs from the first dose of study treatment through 35 (±5) days after the date of patient early discontinuation.

  2. Population slope of the relationship between the change from baseline in QTc intervals and plasma concentrations of SPI-2012 [ Time Frame: Up to 42 days ]
    A linear mixed effects modeling approach will be used to quantify the relationship between the plasma concentrations of SPI-2012 and change from baseline in QT intervals (∆QTc). Plasma concentration, intercept, and subject are to be included as random effects.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03135951

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United States, California
Research Center
Anaheim, California, United States, 92804
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
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Study Director: Zane Yang, MD Spectrum Pharmaceuticals, Inc

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Responsible Party: Spectrum Pharmaceuticals, Inc Identifier: NCT03135951    
Other Study ID Numbers: SPI-GCF-301-PK
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spectrum Pharmaceuticals, Inc:
Breast Cancer
Long-acting Myeloid Growth Factor
Early Stage Breast Cancer
Docetaxel + Cyclophosphamide (TC) Chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators