- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00951054
A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer
February 12, 2015 updated by: Nippon Kayaku Co., Ltd.
A Phase II Study of NK012 in Locally Advanced Non-Resectable and Metastatic Breast Cancer Patients With Triple Negative Phenotype
The purpose of this study is to determine whether NK012 is safe and effective in the treatment of advanced and metastatic triple negative breast cancer.
Study Overview
Detailed Description
This is a Phase II, open label, single arm, multicenter study of NK012 in patients with locally advanced non-resectable and metastatic breast cancer with ER-negative, PR negative and HER2-negative phenotype.
NK012 will be administered by infusion over 30 minutes once every 28 days (on Day 1 of each cycle).
Patients will be screened for UGT1A1 polymorphism prior to enrollment in order to determine their starting dose.
Study Type
Interventional
Enrollment (Anticipated)
61
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of breast cancer with locally advanced disease for which there is no surgical option, or stage IV disease.
- ER-negative and PR-negative (defined as less than or equal to 10% tumor staining).
HER2-negative defined as one of the following:
- 0 or 1+ IHC;
- 2+ or 3+ IHC and FISH negative (ratio < 2.2);
- or FISH negative (ratio < 2.2).
- No less than one and no more than two prior chemotherapy regimens for advanced or metastatic disease.
- Prior chemotherapy must have included a taxane either as part of an adjuvant regimen or as part of a metastatic disease regimen.
- Interval from last dose of prior treatment to enrollment in this study must be at least 4 weeks for cytotoxic chemotherapy (exception: 6 weeks for nitrosoureas or mitomycin C), 5 half-lives for non-cytotoxic therapy (to be reviewed by the Medical Monitor to establish start date), and 4 weeks for monoclonal antibodies; patients must have recovered from all acute toxicities.
- Measurable disease by RECIST.
- ECOG performance status of 0-2.
- Females at least 18 years of age.
- Adequate bone marrow function as defined by absolute neutrophil count of greater than or equal to 1,500/ mm^3 and platelets of greater than or equal to 100,000/mm^3.
- AST(SGOT) and ALT(SGPT) levels no greater than 3 x the institutional ULN, and total bilirubin less than or equal to 1.5 x ULN.
- Serum creatinine less than or equal to 1.5 x ULN, or creatinine clearance greater than or equal to 60 mL/min (Cockcroft-Gault formula) for patients with serum creatinine levels > 1.5 x ULN.
- Able to understand and show willingness to sign a written informed consent document.
Exclusion criteria:
- Patient has Gilbert's Syndrome.
- Concurrent use of other investigational agent.
- History of brain metastases or spinal cord compression, unless irradiated a minimum of 4 weeks before study entry and stable without requirement for corticosteroids for > 1 week.
- Prior exposure to topoisomerase 1 inhibitors (i.e., irinotecan, topotecan, camptothecin).
- Concurrent serious infections requiring parenteral therapy.
- Pregnant or of childbearing potential and not using methods to avoid pregnancy. A negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential. Patients may not breast-feed infants while on this study.
- Significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions, history of myocardial infarction within one year of study entry, uncontrolled dysrhythmias or poorly controlled angina.
- History of serious ventricular arrhythmia (VT or VF, greater than or equal to 3 beats in a row), QTc greater than or equal to 450 msec for men and 470 msec for women, or LVEF less than or equal to 40% by MUGA or ECHO.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Antitumor activity (overall response rate) of NK012
Time Frame: At baseline and after every 2 cycles; PR or CR must be confirmed no less than 4 weeks after the first response was recorded
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At baseline and after every 2 cycles; PR or CR must be confirmed no less than 4 weeks after the first response was recorded
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of response
Time Frame: Monthly for 6 months after patient goes off study, then every 3 months thereafter
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Monthly for 6 months after patient goes off study, then every 3 months thereafter
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Rate and duration of disease control
Time Frame: Monthly for 6 months after patient goes off study, then every 3 months thereafter
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Monthly for 6 months after patient goes off study, then every 3 months thereafter
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Time to disease progression
Time Frame: Monthly for 6 months after patient goes off study, then every 3 months thereafter
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Monthly for 6 months after patient goes off study, then every 3 months thereafter
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Toxicity profile of NK012
Time Frame: Duration of study, and up to 30 days after discontinuation
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Duration of study, and up to 30 days after discontinuation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
February 1, 2015
Study Registration Dates
First Submitted
May 21, 2009
First Submitted That Met QC Criteria
August 2, 2009
First Posted (ESTIMATE)
August 4, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 16, 2015
Last Update Submitted That Met QC Criteria
February 12, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6012211US
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Triple Negative Breast Cancer
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Peregrine PharmaceuticalsWithdrawnBreast Cancer | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | Triple-Negative Breast Cancer | Triple-Negative Breast Neoplasm | ER-Negative PR-Negative HER2-Negative Breast Neoplasms | ER-Negative PR-Negative HER2-Negative Breast Cancer
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Swiss Group for Clinical Cancer ResearchNot yet recruitingTriple-negative Breast Cancer | TNBC - Triple-Negative Breast CancerSwitzerland
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G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
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AkesoRecruitingMetastatic Triple-negative Breast Cancer | Locally Advanced Triple-negative Breast CancerChina
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Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH); MedImmune...TerminatedTriple Negative Breast Cancer | Triple Negative Breast Neoplasms | TNBC - Triple-Negative Breast Cancer | Triple-negative Breast CarcinomaUnited States
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CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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Melinda TelliPfizer; BioMarin PharmaceuticalCompletedAdvanced Breast Cancer | HER2/Neu Negative | Triple-Negative Breast CancerUnited States
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Fudan UniversityNot yet recruitingTriple-negative Breast Cancer
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UNICANCERSOLTI Breast Cancer Research Group; Vall d'Hebron Institute of Oncology; MSD...Not yet recruitingTriple-negative Breast Cancer
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Shanghai Jiao Tong University School of MedicineCSPC Ouyi Pharmaceutical Co., Ltd.; Innovent Biologics, Inc.Not yet recruiting
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Nippon Kayaku Co., Ltd.Completed
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