Pancreatic Neuroendocrine Tumor G2 Clinical Trial
A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)
This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body, does not respond to treatment, or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth.
I. To evaluate overall response rate associated with sapanisertib (MLN0128 [TAK-228]) in patients with advanced pancreatic neuroendocrine tumors (PNETs).
I. To evaluate progression-free survival (PFS) associated with MLN0128 (TAK-228) in patients with advanced pancreatic neuroendocrine tumors (PNETs).
II. To measure the safety and tolerability of MLN0128 (TAK-228) in patients with advanced PNETs.
III. To evaluate disease control rate associated with MLN0128 (TAK-228) in patients with advanced PNETs.
IV. To measure duration of response rate associated with MLN0128 (TAK-228) in patients with advanced PNETs.
Patients receive sapanisertib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years. ;
|Source||National Cancer Institute (NCI)|
|Start date||February 1, 2017|
|Completion date||August 1, 2019|
|Active, not recruiting||