Clinical Trials Directory

Trials / Completed

CompletedNCT02244463

A Phase I/II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer and Incurably Poorly Differentiated or Radioidodine Refractory Differentiated Thyroid Cancer

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Dana-Farber Cancer Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This research study is a phase I/II study of MLN0128 in metastatic anaplastic thyroid cancer(ATC) and incurably poorly differentiated or radioidodine refractory differentiated thyroid cancer (DTC). Due to changes in the manufacturing process which resulted in increased absorption of MLN0128 from capsules, a run-in phase I prior to the phase II of the study was needed. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved MLN0128 as a treatment for any disease. MLN0128 prevents tumor cells from dividing and growing by selectively and potently inhibiting a chemical, mTOR kinase, which regulates cell growth and survival. Patients with anaplastic thyroid cancer have been observed to sometimes carry genetic alterations in their tumor cells which may make the cancer more sensitive to inhibition by MLN0128. Given the activity with everolimus in RAI refractory thyroid cancer, subjects wth metastatic, incurable differentiated RAI refractory and poorly differentiated thyroid cancer were included.

Detailed description

Patients who fulfill eligibility criteria will be entered into the trial to receive MLN0128.

Conditions

Interventions

TypeNameDescription
DRUGMLN0128

Timeline

Start date
2015-07-01
Primary completion
2022-04-28
Completion
2022-04-28
First posted
2014-09-19
Last updated
2024-01-12
Results posted
2024-01-12

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02244463. Inclusion in this directory is not an endorsement.