- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00951613
A Study of NK012 in Patients With Relapsed Small Cell Lung Cancer
March 18, 2013 updated by: Nippon Kayaku Co., Ltd.
A Phase II Study of NK012 in Sensitive Relapsed and Refractory Relapsed Small-Cell Lung Cancer (SCLC)
The purpose of this study is to determine whether NK012 is safe and effective in the treatment of relapsed small cell lung cancer.
Study Overview
Detailed Description
This is a Phase II, open label, single arm, multicenter study of NK012 in patients with sensitive relapsed SCLC (at least 90 days since first line therapy) or refractory relapsed SCLC (< 90 days since first line therapy).
NK012 will be administered by intravenous infusion over 30 minutes once every 28 days (on Day 1 of each cycle).
Patients will be screened for UGT1A1 polymorphism prior to enrollment.
Study Type
Interventional
Enrollment (Actual)
72
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
All
Description
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of SCLC, which has relapsed after first line chemotherapy for extensive-stage SCLC or first-line chemoradiotherapy for limited-stage SCLC.
- Have received one, and only one, prior chemotherapy or chemoradiotherapy regimen for either newly diagnosed extensive-stage disease or limited-stage disease.
- Prior therapies must be completed at least 4 weeks prior to enrollment and patients must have recovered from all acute toxicities.
- Measurable disease by RECIST.
- ECOG performance status of 0-2.
- 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.
- Prior chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Lack of recovery from adverse effects due to agents administered more than 4 weeks prior to study entry.
- 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 Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the overall 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 |
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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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Progression-free survival
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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Overall survival
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 off-study
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Duration of study and up to 30 days after off-study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David R Spigel, MD, SCRI Development Innovations, LLC
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
July 1, 2009
Primary Completion (Actual)
January 1, 2012
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)
March 20, 2013
Last Update Submitted That Met QC Criteria
March 18, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6012212US
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.
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