Clinical Trials /

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

NCT01948843

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer
  • Official Title: Phase 1 Trial of ADI-PEG 20 Plus Doxorubicin in Patients With HER2 Negative Metastatic Breast Cancer or Advanced Solid Tumor

Clinical Trial IDs

  • ORG STUDY ID: POLARIS2013-004
  • NCT ID: NCT01948843

Conditions

  • HER2 Negative Metastatic Breast Cancer

Interventions

DrugSynonymsArms
ADI-PEG 20ADI-PEG 20

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
ADI-PEG 20Experimentalarginine deiminase formulated with polyethylene glycol
  • ADI-PEG 20

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Adverse Events
Time Frame:2 years estimated - course of study
Safety Issue:
Description:Assessment of safety and tolerability of ADI-PEG 20 in combination with doxorubicin in HER2 negative metastatic breast cancer

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Polaris Group

Trial Keywords

  • HER2 Negative Metastatic Breast Cancer

Last Updated

April 13, 2016