A Study to testABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System
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|ClinicalTrials.gov Identifier: NCT03670030|
Recruitment Status : Terminated (Slow enrollment)
First Posted : September 13, 2018
Results First Posted : June 10, 2021
Last Update Posted : June 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: ABI-009||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase 2 Study of Albumin-bound Rapamycin Nanoparticles, ABI-009, in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System|
|Actual Study Start Date :||November 5, 2018|
|Actual Primary Completion Date :||January 1, 2021|
|Actual Study Completion Date :||February 26, 2021|
In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle.
rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)
Other Name: nab-rapamycin
- Disease Control Rate at 6 Months Per RECIST v1.1. [ Time Frame: 6 months ]
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.
- Percent of Subjects Experiencing Adverse Events [ Time Frame: Continuous from the signing of the informed consent to 28 days after last study treatment, on average 6 months ]Percent of subjects with >=5% adverse events or grades 3 or 4 adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670030
|United States, Louisiana|
|Ochsner Clinic Foundation|
|New Orleans, Louisiana, United States, 70121|
|Principal Investigator:||Robert Ramirez, DO||Ochnser Clinic Foundation|