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

September 11, 2013
August 7, 2014
April 2014
April 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01948843 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer
Phase 1 Trial of ADI-PEG 20 Plus Doxorubicin in Patients With HER2 Negative Metastatic Breast Cancer or Advanced Solid Tumor

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HER2 Negative Metastatic Breast Cancer
Drug: ADI-PEG 20
Experimental: ADI-PEG 20
arginine deiminase formulated with polyethylene glycol
Intervention: Drug: ADI-PEG 20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
July 2016
April 2016   (final data collection date for primary outcome measure)

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.

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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.
Female
18 Years and older
No
Contact: Rupal Patel 858-452-6688 ext 133 rpatel@polaripspharma.com
United States
 
NCT01948843
POLARIS2013-004
No
Polaris Group
Polaris Group
Not Provided
Principal Investigator: Siqing Fu, MD MD Anderson
Polaris Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP