Clinical Trial: MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma

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

Official Title: MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma

Brief 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 Summary:

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.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome:

  • Maximum Tolerated Dose (MTD) [ Time Frame: 56 days ]
    Based on MTD in phase I, the recommended dose for phase II (RP2D) will be determined
  • Overall Response Rate (ORR) [ Time Frame: From registration to up to 2 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Survival (OS) [ Time Frame: From registration to up to 2 years ]
  • Progression-free survival (PFS) [ Time Frame: From registration to up to 2 years ]
  • Adverse Events (AEs) [ Time Frame: 30 days before registration to 30 days after the last dose ]
  • Response Biomarkers including p4EBP1, PSK6, pCAD and Merkel cell polyomavirus (MCV) Large T antigen (LT) and small T antigen (ST) [ Time Frame: From registration to up to 2 years ]


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: July 28, 2015
Date Started: October 2015
Date Completion: July 2020
Last Updated: December 29, 2016
Last Verified: December 2016