A Multicenter Phase I Study of TCD-717 Given by 4-Hour Intravenous Infusion in Patients with Advanced Solid Tumors
This research study is being done to determine if the investigational drug TCD-717 is generally safe, tolerable and effective in people with advanced solid tumor cancer. In this clinical study, we want to find out what effects, good and/or bad, TCD-717 has on you and how effective it is against your type of cancer. The way that TCD-717 works is not fully understood, but it is known this drug targets and kills cancer cells from a range of solid tumors.
Adult patients (18 & older) with solid tumor that is refractory to standard treatments available and metastatic or un-resectable. You must have an adequate performance status as determined by research team at screening based n your daily activities and function with activities of daily living. You must have measurable disease or have disease that can be tracked /followed by radiologic scans. Normal kidney and liver function, as well as adequate blood counts are required. Known brain disease/metastasis is allowed if proven stable with no need for steroid usage. Unstable brain disease is not allowed. No treatment of any kind (radiation, surgery, chemotherapy or clinical trial) in prior 4 weeks. (Prior treatment restricted to 6 weeks if treated with nitrosureas or Mitomycin-C). No history of prior extensive Radiation therapy (greater than 30% of bone marrow affected by therapy. No prior bone marrow transplant. No hematologic malignancy (blood cancer. No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements. No history of prior cardiac disease (NYHA class III or IV : myocardial infarction (heart attack),uncontrolled arrhythmias, poorly controlled angina, uncontrolled high blood pressure, or uncontrolled tachycardia. No QTc greater than 450 for men and no QTc greater than 470 for women as determined by pre-study collected EKG(electrocardiogram). No LVEF(left ventricular ejection fraction) less than 50% as determined by pre-study echocardiogram or MUGA scan. No clinical evidence of bleeding or history of bleeding disorders. No use of anticoagulant drugs. No evidence of aPTT outside of normal limits (as determined by pre-study blood work) No pregnant women. All patients of child bearing potential must agree to use adequate contraception during study and for 6 months after completing study drug. No HIV/Hepatitis positive patients. Your current daily medications will need to be reviewed with the study team to determine if they may interfere with the study drug. No evidence of retinal abnormalities (i.e. macular degeneration, retinitis) as determined by pre-study eye exam.
TCD-717 is an intravenous medication that will be infused through a central venous access device twice each week over a period of 4 hours. Patient must be seen for labs weekly. Physical exam once a month at the beginning of every 28 day cycle of therapy. Other blood work, EKGâ??s(electrocardiograms) and vital signs will be taken pre-infusion and for 2 â?? 4 hours post infusions on all treatment visits (twice weekly). Patients will be assessed for disease response every 2 months.
05/20/2013 04:02 AM