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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Study of TAK-228 in Everolimus-Refractory Advanced Pancreatic Neuroendocrine Tumors (PNET)

Brief 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

Detailed Summary:

PRIMARY OBJECTIVES:

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

SECONDARY ENDPOINTS:

I. To evaluate progression-free survival (PFS) associated with TAK-228 in patients with advanced pancreatic neuroendocrine tumors (PNETs).

II. To measure the safety and tolerability of TAK-228 in patients with advanced PNETs.

III. To evaluate disease control rate associated with TAK-228 in patients with advanced PNETs.

IV. To measure duration of response rate associated with 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 and then every 6 months for 3 years.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Objective tumor response (complete response + partial response) as evaluated by RECIST version 1.1 [ Time Frame: Up to 5 years ]

If at the end of the second stage, 4 or more patients attain objective response to therapy, the null hypothesis will be rejected and the agent will be recommended for further evaluation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease control rate [ Time Frame: Up to 5 years ]
    Analysis will be descriptive in nature.
  • Duration of response [ Time Frame: Up to 5 years ]
    Analysis will be descriptive in nature.
  • Incidence of adverse events as graded by CTCAE version 4.0 [ Time Frame: Up to 5 years ]
  • PFS [ Time Frame: Up to 5 years ]
    Analysis will be descriptive in nature.


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 8, 2016
Date Started: February 2017
Date Completion:
Last Updated: April 18, 2017
Last Verified: March 2017