NCT02514824

MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a targeted therapy as a possible treatment for merkel cell carcinoma. \- The name of the study intervention involved in this study is: MLN0128.

Detailed description

This is a phase I/II clinical trial. A phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "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 may prevent tumor cells from dividing and growing by selectively and potently inhibiting a chemical, mTOR kinase, which regulates cell growth and survival. Patients with merkel cell carcinoma have been observed to sometimes carry genetic alterations in their tumor cells which may make the cancer more sensitive to inhibition by MLN0128. In this research study,the investigators are studying the usefulness of MLN0128 in merkel cell carcinoma cases.

Conditions

• Merkel Cell Carcinoma

Interventions

Type	Name	Description
DRUG	MLN0128	Investigational mTOR kinase inhibitor

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2015-08-04
• Last updated: 2020-12-29
• Results posted: 2020-12-29

Locations

1 site across 1 country: United States