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RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (ADVANCE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT02643420
First received: December 29, 2015
Last updated: August 7, 2017
Last verified: August 2017
  Purpose
The purpose of this study is to compare the efficacy of a single dose of SPI-2012 with pegfilgrastim (Neulasta [NDC 55513-190-01] manufactured by Amgen) in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the Duration of Severe Neutropenia (DSN) in Cycle 1.

Condition Intervention Phase
Neutropenia Breast Cancer Drug: SPI-2012 Drug: Pegfilgrastim Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Duration of severe neutropenia (DSN) in Cycle 1 [ Time Frame: Up to 21 days ]
    DSN is defined as the number of days of severe neutropenia (ANC <0.5×10^9/L) from the first occurrence of an ANC below the threshold.


Secondary Outcome Measures:
  • Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 [ Time Frame: Up to 21 days ]
  • Depth of ANC Nadir, defined as the patient's lowest ANC in Cycle 1 [ Time Frame: Up to 21 days ]
  • Incidence of Febrile Neutropenia (FN) in patients during Cycle 1 [ Time Frame: Up to 21 days ]
    Febrile neutropenia (FN) will be evaluated through daily temperature monitoring to assess for fever and frequent CBCs to assess for neutropenia.


Enrollment: 405
Actual Study Start Date: December 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPI-2012
  • SPI-2012 (13.2 mg/0.6 mL fixed dose, equivalent to 3.6)
  • Supplied in prefilled single-use syringes for subcutaneous injection
  • Administered on Day 2 of each cycle
Drug: SPI-2012
Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle.
Active Comparator: Pegfilgrastim
  • Pegfilgrastim (6 mg/0.6 mL) (Neulasta® [NDC 55513-190-01] manufactured by Amgen)
  • Single-dose subcutaneous injection administered on Day 2 of each cycle
Drug: Pegfilgrastim
Single-dose subcutaneous injection administered on Day 2 of each cycle.
Other Name: Neulasta®

Detailed Description:

This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 (a long acting myeloid growth factor) with pegfilgrastim (Neulasta [NDC 55513-190-01] manufactured by Amgen) in breast cancer patients treated with TC chemotherapy.

Approximately 400 patients will be enrolled and randomized in a 1:1 ratio to 2 treatment arms.

Each cycle will be 21 days. Only 4 cycles will be evaluated for this study. On Day 1 of each cycle, patients will receive TC chemotherapy. On Day 2 of each cycle, patients will receive study drug (SPI-2012 or pegfilgrastim).

  Eligibility

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

Key Inclusion Criteria:

  • 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 neo-adjuvant TC chemotherapy.
  • ECOG ≤2.
  • ANC ≥1.5×10^9/L
  • Platelet count ≥100×10^9/L
  • Hemoglobin >9 g/dL
  • Calculated creatinine clearance > 50 mL/min
  • Total bilirubin ≤1.5 mg/dL
  • AST/SGOT and ALT/SGPT ≤2.5×ULN
  • Alkaline phosphatase ≤2.0×ULN

Key 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 or known sensitivity to any of the products to be administered during dosing
  • Concurrent adjuvant cancer therapy
  • Locally recurrent/metastatic
  • 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 or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment
  • Prior bone marrow or 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02643420

Locations
United States, Tennessee
The West Clinic
Germantown, Tennessee, United States, 38138
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Jose L Martinez, MD Spectrum Pharmaceuticals, Inc
  More Information

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02643420     History of Changes
Other Study ID Numbers: SPI-GCF-301
Study First Received: December 29, 2015
Last Updated: August 7, 2017

Keywords provided by Spectrum Pharmaceuticals, Inc:
Neutropenia
Breast Cancer
Long-acting Myeloid Growth Factor
Early Stage Breast Cancer
Docetaxel + Cyclophosphamide (TC) chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Cyclophosphamide
Docetaxel
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

ClinicalTrials.gov processed this record on September 21, 2017