A Study to Test the Effectiveness of ABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03670030|
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : February 8, 2019
|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)|
|Estimated Enrollment :||10 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|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
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 [ Time Frame: 6 months ]Assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Adverse Event Assessment [ Time Frame: Continuous from the signing of the informed consent to 28 days after last study treatment ]Collection of any 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
|Contact: Heather Scuderiemail@example.com|
|Principal Investigator:||Robert Ramirez, DO||Ochnser Clinic Foundation|