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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
30 minute IV infusion once every 28 days. NK012 dose is 28 mg/m\^2 (or 18 mg/m\^2 depending on UGT1A1 polymorphism, with potential to dose escalate). Dose escalation cannot exceed 28 mg/m\^2. Dosing will proceed until progression or unacceptable toxicity develops, or decision by patient or investigator to stop.
Sarah Cannon Research Institute
Nashville, Tennessee, United States
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
Duration of response
Time frame: Monthly for 6 months after patient goes off study, then every 3 months thereafter
Rate and duration of disease control
Time frame: Monthly for 6 months after patient goes off study, then every 3 months thereafter
Time to disease progression
Time frame: Monthly for 6 months after patient goes off study, then every 3 months thereafter
Toxicity profile of NK012
Time frame: Duration of study, and up to 30 days after discontinuation
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