Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT00542958
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00542958
Study Brief:
Protocol Section:
NCT00542958