Expired Study
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Nashville, Tennessee 37203


Purpose:

The purpose of this study is to determine whether NK012 is safe and effective in the treatment of refractory solid tumors


Study summary:

This is a Phase I dose-escalation study of the intravenous administration of NK012 in patients with refractory solid tumors. Patients will receive NK012 as an intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients with UGT1A1*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/*28) variants as one group, and patients with UGT1A1*28 homozygous variant (*28/*28) as another group.


Criteria:

Inclusion Criteria: - Histologically confirmed malignant solid tumor for which there are no known regimens or protocol treatments of higher efficacy or priority - Failed conventional therapy for the cancer or have a malignancy for which a conventional therapy does not exist - Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss) - Life expectancy of at least 12 weeks and an EOCG performance status of 0 or 1 - 18 years of age or older - Adequate kidney, liver, and bone marrow function - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse effects due to agents administered more than 4 weeks earlier - Receiving any 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 - History of allergic reactions attributed to compounds of similar chemical composition to NK012 - Concurrent serious infections (i.e., requiring an intravenous antibiotic) - Pregnant women or women of childbearing potential who are not using methods to avoid pregnancy; a negative pregnancy test (urine or serum) must be documented at baseline and before every NK012 administration for women of childbearing potential; no breast-feeding while on study - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements - Significant cardiac disease - History of serious ventricular arrhythmia - Positive for anti-HbsAg, anti-HCV, anti-HIV, or anti-syphilis antibodies


NCT ID:

NCT00542958


Primary Contact:

Principal Investigator
Howard A. Burris, III, MD
Sarah Cannon Research Institute


Backup Contact:

N/A


Location Contact:

Nashville, Tennessee 37203
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 22, 2017

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