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Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer

NCT01948843 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-04-14

No results posted yet for this study

Summary

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. In this study, ADI will be combined with the well known chemotherapy Doxorubicin and the safety and potential efficacy of this combination will be explored in patients with HER2 Negative Metastatic Breast Cancer.

Conditions

  • HER2 Negative Metastatic Breast Cancer

Interventions

DRUG

ADI-PEG 20

Sponsors & Collaborators

  • Polaris Group

    lead INDUSTRY

Principal Investigators

  • Siqing Fu, MD · MD Anderson

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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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 NCT01948843 on ClinicalTrials.gov