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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Polaris Group
Sponsor:
Information provided by (Responsible Party):
Polaris Group
ClinicalTrials.gov Identifier:
NCT01948843
First received: September 11, 2013
Last updated: August 7, 2014
Last verified: August 2014
  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.


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: July 2016
Estimated Primary Completion Date: April 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. 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.
  9. No prior systemic therapy, immunotherapy, investigational agent, or radiation therapy within the last 3 weeks.
  10. Fully recovered from any prior surgery and no major surgery within 4 weeks of initiating treatment. Surgery for placement of vascular access devices is acceptable.

    -

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.
  9. History of seizure disorder not related to underlying cancer.
  10. ECOG performance status > 2.
  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: NCT01948843

Contacts
Contact: Rupal Patel 858-452-6688 ext 133 rpatel@polaripspharma.com

Locations
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77230
Contact: John Bomalaski, MD    858-452-6688 ext 114    jbomalaski@polarispharma.com   
Principal Investigator: Siqing Fu, MD         
Sponsors and Collaborators
Polaris Group
Investigators
Principal Investigator: Siqing Fu, MD MD Anderson
  More Information

No publications provided

Responsible Party: Polaris Group
ClinicalTrials.gov Identifier: NCT01948843     History of Changes
Other Study ID Numbers: POLARIS2013-004
Study First Received: September 11, 2013
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Polaris Group:
HER2 Negative Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014