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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01516307
Other study ID # OPT-822-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2011
Est. completion date August 2019

Study information

Verified date September 2020
Source OBI Pharma, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.


Recruitment information / eligibility

Status Completed
Enrollment 349
Est. completion date August 2019
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Female subjects = 21 years of age with histological or cytological diagnosis of breast carcinoma.

- Subjects with metastatic breast cancer who have achieved stable disease (SD), partial response (PR), or complete response (CR) after at least 1 regimen of anticancer therapy (i.e. chemotherapy or target therapy, either alone or in any combination). Involvement of supraclavicular lymph node is considered metastasis.

- Subjects must have recovered from toxicities of prior therapies. (i.e. CTCAE = grade 2).

- Performance status: ECOG = 1 and life expectancy = 3 months.

- Organ Function Requirements - Subjects must have adequate organ functions as defined below:

- AST/ALT = 3X ULN (upper limit of normal)

- AST/ALT = 5X ULN [with underlying Liver Metastasis]

- Total Bilirubin = 2.0 X ULN

- Serum Creatinine = 1.5X ULN

- ANC = 1500 /µL

- Platelets > 100,000/µL

- No Symptomatic Congestive Heart Failure (Ejection Fraction EF = 50%)

- Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.

- All positive or negative ER (estrogen receptor), PR (progesterone receptor), and HER-2 subjects are eligible for this study.

- However, subjects who are HER-2 positive and responsive to anti-HER-2 therapy (e.g. Herceptin), are encouraged to remain on anti-HER-2 therapy and not enroll in this trial.

- Subjects who desire to enroll in this study and for whom anti-HER-2 therapy is not available or contraindicated, may be eligible to enroll in this trial.

- In countries where continuous anti-HER2 therapy is considered standard of care for HER-2 positive metastatic disease, HER-2 positive subjects are not eligible.

- Women of childbearing potential must be willing to implement adequate contraception during the study. An adequate method of contraception will be at the investigator's discretion.

Exclusion Criteria:

- Subjects are pregnant or breast-feeding at entry.

- Subjects with more than 2 events of disease progression after the development of metastatic breast cancer.

- Subjects who are currently receiving any other concomitant anticancer therapy with the EXCEPTION of bisphosphonates and hormone therapy.

- During the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen.

- However, if a change in hormonal therapy is indicated, e.g. due to intolerable adverse effects, the regimen may be modified but change should be minimized thereafter.

- Subjects with metastasis limited to the bone only are excluded. However, subjects with current metastasis limited to the bone only and with a history of distant metastasis are eligible. Subjects with current metastasis limited to the bone only and with current breast tissue lesion are eligible.

- Subjects who have any history of other malignancy (except non-melanoma skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry.

- Subjects with splenectomy.

- Subjects with HIV infection.

- Subjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies.

- e.g. Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave's disease, Hashimoto's thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc

- Autoimmune disorders confined to the skin (e.g. psoriasis) are eligible, and topical steroids are allowed for the treatment of such skin disorders.

- Subjects with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

- Subjects with any of the following MEDICATIONS within 4 weeks prior to randomization:

- Anti-neoplastic agents

- Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]

- Immunosuppressants (e.g. Cyclosporin, Rapamycin, Tacrolimus, Rituximab, Alemtuzumab, Natalizumab, etc.).

- Another investigational drug

- Subjects with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.

- Subjects with any known severe allergies (e.g. anaphylaxis) to any active or inactive ingredients in the study drugs.

- Subjects with bladder inflammation and urinary outflow obstruction.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
OPT-822/OPT-821(30 µg/100 µg)
Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. OPT-822 and OPT-821 are combined at time of injection.
Phosphate Buffer Saline (PBS)
Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.
Drug:
Cyclophosphamide
Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.

Locations

Country Name City State
China UNIMED Medical Institute Hong-Kong
India HCG, Bangalore Institute of Oncology Bengaluru
India Curie Manavata Cancer Centre Mumbai
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Pusan National University Hospital Busan-si
Korea, Republic of Inha University Hospital Chungcheongbuk-Do
Korea, Republic of National Cancer Center Chungcheongbuk-Do
Korea, Republic of Kyungpook National University Medical Center Daegu
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Seoul National University Hospital , Seoul
Korea, Republic of Seoul St. Mary's Hospital Seoul
Korea, Republic of Severance Hospital Seoul
Taiwan Changhua Christian Hospital Changhua
Taiwan Chang Gung Memorial Hospital-KS Kaohsiung
Taiwan Kaohsiung Medical University Hospital Kaohsiung City
Taiwan Kaohsiung Veterans General Hospital Kaohsiung City
Taiwan Chang Gung Memorial Hospital -Linkou Linkou
Taiwan Mackay Memorial Hospital New Taipei City
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Chi Mei Medical Center Tainan City
Taiwan Chang Gung Memorial Hospital-Taipei Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Shuang-Ho Hospital Taipei
Taiwan Tri-Service General Hospital Taipei
Taiwan Koo Foundation Sun Yat-Sen Cancer Center Taipei City
Taiwan Taipei Veterans General Hospital Taipei City
United States Hope Women's Cancer Center Asheville North Carolina
United States The University of Alabama at Birmingham (UAB) Birmingham Alabama
United States University of Chicago Medical Center Chicago Illinois
United States St. Jude Heritage Healthcare, Virginia K. Crosson Cancer Center Fullerton California
United States Memorial Regional Hospital Hollywood Florida
United States University of Texas MD Anderson Cancer Center Houston Texas
United States University of California, San Diego (UCSD) La Jolla California
United States Weill Cornell Medical College New York New York
United States University of California, Irvine (UCI) Orange California
United States University of California, San Francisco (UCSF) San Francisco California
United States Coastal Integrative Cancer Care San Luis Obispo California
United States Central Coast Medical Oncology Corporation Santa Maria California
United States University of California, Los Angeles (UCLA) Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
OBI Pharma, Inc

Countries where clinical trial is conducted

United States,  China,  India,  Korea, Republic of,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) Progression or up to 2 years
Secondary Overall Survival (OS) 5 years
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