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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Polaris Group Identifier:
First received: September 11, 2013
Last updated: August 26, 2015
Last verified: August 2015

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.

Condition Intervention Phase
HER2 Negative Metastatic Breast Cancer
Drug: ADI-PEG 20
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Trial of ADI-PEG 20 Plus Doxorubicin in Patients With HER2 Negative Metastatic Breast Cancer or Advanced Solid Tumor

Resource links provided by NLM:

Further study details as provided by Polaris Group:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 2 years estimated - course of study ] [ Designated as safety issue: Yes ]
    Assessment of safety and tolerability of ADI-PEG 20 in combination with doxorubicin in HER2 negative metastatic breast cancer

  • Determine preliminary estimates of efficacy, measured by RECIST 1.1 criteria, for ADI-PEG 20 combo with doxorubicin in HER2 negative metastatic breast cancer. [ Time Frame: 2 years estimated - course of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADI-PEG 20
arginine deiminase formulated with polyethylene glycol
Drug: ADI-PEG 20


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Biopsy proven HER2 negative metastatic breast cancer (dose escalation portion and MTD expansion portion) or advanced solid tumor (dose escalation portion).
  2. ASS deficiency (defined as <50% ASS expression) demonstrated on tissue specimen by Immunohistochemistry (IHC). Cytology and fine need aspirate specimens are not acceptable for ASS testing.
  3. Unresectable disease or subject refused surgery.
  4. Measurable disease as assessed by RECIST 1.1 criteria (Appendix A).
  5. Failed available therapy known to confer clinical benefit but no more than 4 prior lines of chemotherapy for metastatic disease.
  6. Time to treatment failure from doxorubicin containing regimen ≥ 12 months if previously treated with doxorubicin.
  7. Age ≥ 18 years.
  8. ECOG performance status of 0 - 2. -

Exclusion Criteria:

  1. Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
  2. Prior epirubicin exposure of > 600 mg/m2.
  3. Pregnancy or lactation.
  4. Expected non-compliance.
  5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
  6. Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and Investigator may be allowed upon agreement with both.
  7. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of breast cancer diagnosis.
  8. Subjects who had been treated with ADI-PEG 20 previously.
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Please refer to this study by its identifier: NCT01948843

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77230
Sponsors and Collaborators
Polaris Group
Principal Investigator: Siqing Fu, MD MD Anderson
  More Information

No publications provided

Responsible Party: Polaris Group Identifier: NCT01948843     History of Changes
Other Study ID Numbers: POLARIS2013-004
Study First Received: September 11, 2013
Last Updated: August 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Polaris Group:
HER2 Negative Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on October 02, 2015