A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer

NCT00951054 | Completed Phase 2 DMC

• 1 other identifier: A6012211US
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Triple Negative Breast Cancer

Keywords

breast cancer; triple negative; ER-negative; PR-negative; HER2-negative; ER-, PR-, HER2- (Triple Negative) breast cancer

Outcome Measures

Primary Outcomes (1)

• Antitumor activity (overall response rate) of NK012

  At baseline and after every 2 cycles; PR or CR must be confirmed no less than 4 weeks after the first response was recorded

Secondary Outcomes (4)

• Duration of response

  Monthly for 6 months after patient goes off study, then every 3 months thereafter

• Rate and duration of disease control

  Monthly for 6 months after patient goes off study, then every 3 months thereafter

• Time to disease progression

  Monthly for 6 months after patient goes off study, then every 3 months thereafter

• Toxicity profile of NK012

  Duration of study, and up to 30 days after discontinuation

Interventions

NK012 DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• or 1+ IHC;
• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nippon Kayaku Co., Ltd.: lead

Study Sites (1)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Denise A Yardley, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: August 4, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

US (1)