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Clinical Trial Summary

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.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate overall response rate associated with sapanisertib (MLN0128 [TAK-228]) in patients with advanced pancreatic neuroendocrine tumors (PNETs).

SECONDARY ENDPOINTS:

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.

OUTLINE:

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02893930
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Recruiting
Phase Phase 2
Start date February 1, 2017
Completion date August 1, 2019