Clinical Trials Directory

Trials / Completed

CompletedNCT02893930

Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery

A Phase II Study of MLN0128 (TAK-228) in Rapalog-Resistant Advanced Pancreatic Neuroendocrine Tumors (PNET)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
13 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 (metastatic), does not respond to treatment (refractory), 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.

Detailed description

PRIMARY OBJECTIVE: 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. Cycles 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.

Conditions

Interventions

TypeNameDescription
DRUGSapanisertibGiven PO

Timeline

Start date
2017-04-28
Primary completion
2021-05-11
Completion
2022-12-21
First posted
2016-09-09
Last updated
2023-10-17
Results posted
2022-04-05

Locations

405 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02893930. Inclusion in this directory is not an endorsement.