Clinical Trial: Cabozantinib in Recurrent/Metastatic Merkel Cell Carcinoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Cabozantinib in Recurrent/Metastatic Merkel Cell Carcinoma

Brief Summary: This is an open-label, non-randomized, phase 2 study to assess the feasibility of using cabozantinib in recurrent/metastatic Merkel Cell Carcinoma patients that progressed after platinum-based therapy.

Detailed Summary:

Cabozantinib (XL184) is an inhibitor of multiple receptor tyrosine kinases and was approved by the U.S. Food and Drug Administration (FDA) on 29 November 2012 for the treatment of patients with progressive, metastatic medullary thyroid cancer. It is commercially available as COMETRIQ™ in the United States.

During the Pre Treatment Period, participants are consented and qualified (screened) for the study. Treatment will be administered on an outpatient basis.

Each treatment cycle lasts 28 days, during which time the participant will be taking the study drug, cabozantinib, once daily. The participant will be given a study drug-dosing diary for each treatment cycle. The diary will also include special instructions for taking the study drug.

- Participants will be followed for 8 weeks after removal from study or until death, whichever occurs first. Participants removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Disease Control Rate [ Time Frame: 3 Months ]

The disease control rate is defined as the rate of complete response (CR), partial response (PR), or stable disease (SD) as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression-Free and Overall Survival [ Time Frame: 2 Years ]
    To determine progression-free survival and overall survival of patients receiving cabozantinib for Merkel Cell Carcinoma.
  • Adverse Events [ Time Frame: 2 Years ]
    To determine the frequency and severity of adverse events as assessed by using common terminology criteria for adverse events (CTCAE) version 4.0.
  • Expression of c-MET, phospho-MET and VEGFR-2 on tumor tissue [ Time Frame: 2 Years ]
    To retrospectively correlate the expression of c-MET, phospho-MET and VEGFR-2 on tumor tissue with clinical outcome.


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: December 19, 2013
Date Started: January 2014
Date Completion: January 2019
Last Updated: May 19, 2017
Last Verified: May 2017