Because the decision to participate in an experimental mesothelioma clinical trial is such a complex one requiring a lot of thought and planning, this month for our monthly experimental clinical trial blog post, we are presenting you with one that hasn’t even started recruiting yet. The research scientists and the drug company they are teaming with for this mesothelioma clinical trial are still getting all their ducks in a row. But it’s been listed on the U.S. government’s official clinical trial website so it’s a go. This may be a good chance to get in on the ground floor with enough time to weigh all the pros and cons with your oncologist and your family.
Bonus – The pharmaceutical company sponsoring this mesothelioma clinical trial arranged to have it conducted by a leading Harvard-affiliated research hospital Brigham and Women’s Hospital. Located in Boston, Massachusetts, it is a respected medical institution that resulted from the merger of three of Harvard-affiliated hospitals each of which has a history dating back over 100 years.
First received – December 2, 2013
Last updated – August 8, 2014
Sponsor – Verastem, Inc.
Investigators – Brigham and Women’s Hospital
Purpose – Timing, it’s been said, is everything. This mesothelioma clinical trial is testing the role of timing in medication before surgery. Subjects will receive a medication,VS-6063 (defactinib), for 12 days. Pre- and post-treatment biopsies and blood samples will be collected and responses from tumor tissue will be measured.
Discussion of Outcome Measures – In addition to comparing how tumor tissue responds to VS-6063 (defactinib) from the first day to the twelfth day, the study will also evaluate the safety of the treatment. Participants will be monitored for six weeks to check for any adverse reactions to the treatment.
Estimated enrollment – 20
Study start date – December 2013
Estimated Study Completion Date – January 2015
Estimated Primary Completion Date – November 2014
Eligibility – Confirmed malignant pleural mesothelioma, eligible to undergo surgery such as extrapleural pneumonectomy (EPP) or pleurectomy/decortication (P/DC) or any other mesothelioma surgery but have not yet had chemotherapy or radiation treatments.
Contacts and locations – Brigham and Women’s Hospital, Boston MA
Recruiting Contacts -Julianne Barlow 617-525-8541 jbarlow1@partners.org,
Raphael Bueno, M.D. 617-732-8148 rbueno@partners.org