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Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer

NCT01724866 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2022-04-15

Study results available
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Summary

The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.

Conditions

Interventions

DRUG

SPI-2012

SPI-2012 SC injection.

DRUG

Pegfilgrastim

Pegfilgrastim SC injection, per manufacturer's Prescribing Information.

DRUG

Docetaxel

Docetaxel given based on standard dose for chemotherapy.

DRUG

Cyclophosphamide

Cyclophosphamide given based on standard dose for chemotherapy.

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-25
Primary Completion
2014-08-12
Completion
2014-08-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Georgia
  • Hungary
  • Israel
  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01724866 on ClinicalTrials.gov