The purpose of this study is to determine whether ABI-009 will make advanced, malignant neuroendocrine tumor(s) of the lung, gastrointestinal tract and/or pancreas that cannot be removed by surgery smaller and slow the spread of your cancer in patients who have progressed or been intolerant to everolimus. All eligible participants will receive ABI-009, the study drug.
ABI-009, human albumin-bound rapamycin, is an experimental drug. "Experimental" means that the drug has not been approved by the Food and Drug Administration (FDA). Rapamycin, the active part of the drug, inhibits a biological pathway (mTOR) that certain cancers use to grow. Rapamycin and similar types of drugs have been used in many other tumors, including advanced renal cell carcinoma. A standard mTOR inhibitor used in neuroendocrine tumors is everolimus. The human albumin component of ABI-009 may allow rapamycin to reach cancer cells more effectively. ABI-009 has not been approved for the treatment of advanced, malignant neuroendocrine tumors of the lung, gastrointestinal tract and/or pancreas. The information from this study might help us identify if ABI-009 is safe and effective in this disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Disease Control Rate at 6 Months Per RECIST v1.1.
Disease control rate at 6 months is the proportion of patients who have partial or complete response or stable disease at 6 months. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 6 months
Percent of Subjects Experiencing Adverse Events
Percent of subjects with \>=5% adverse events or grades 3 or 4 adverse events
Time frame: Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months
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