Study of NK012 in Patients With Refractory Solid Tumors

Completed · Phase 1

Conditions studied: Cancer

In brief

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

Key facts

Study ID

NCT00542958

Run by

Nippon Kayaku Co., Ltd.

People needed

39

Starts

2007-03-01

Expected to finish

2011-12-01

Last updated by the study team

2019-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.