Window of Opportunity Study of VS-6063 (Defactinib) in Participants With Surgical Resectable Malignant Pleural Mesothelioma.



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/17/2018
Start Date:December 2013
End Date:September 2019
Contact:Laura Massey
Email:lmassey@verastem.com
Phone:781-469-1542

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An Open Label Window of Opportunity Phase II Study of the FAK Inhibitor Defactinib VS-6063 in Participants With Surgical Resectable Malignant Pleural Mesothelioma.

This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery)
study in subjects with malignant pleural mesothelioma who are eligible for surgery. Subjects
will receive VS-6063 (defactinib) 400 mg twice daily for 12, 21, or 35 days. Pre- and
post-treatment biopsies and blood samples will be collected. The purpose of this study is to
assess biomarker responses from tumor tissue. The safety, pharmacokinetics, and tumor
response rate to VS-6063 (defactinib) will be also be assessed.


Inclusion Criteria:

- Histologically confirmed malignant pleural mesothelioma that is not metastatic or
unresectable

- Eligible to undergo excisional surgery such as pleurectomy/decortication (P/DC) or any
other mesothelioma surgery.

- Localized disease. The malignancy is confined to one affected hemithorax. Mediastinal
N2 lymph nodes via cervical mediastinoscopy or EBUS (endobronchial ultrasound) must be
negative in order to be eligible

- Grossly normal pulmonary, cardiac function, renal, hepatic hematologic and performance
functions

- Male or non-pregnant female

- Age ≥ 18 years of age

- Tissue is required prior to enrollment. If patient was diagnosed outside and tumor
tissue is not available, a pleural biopsy for frozen tissue collection is required.

Exclusion Criteria:

- Participants who have had chemotherapy or radiotherapy any time prior to entering the
study or at any prior time for mesothelioma. Patients receiving chemotherapy type
drugs for benign conditions can participate in this trial

- History of upper gastrointestinal bleeding, ulceration, or perforation within 12
months prior to the first dose of study drug

- Known history of Gilbert's Syndrome or any current hyperbilirubinemia of any cause

- Known history of stroke or cerebrovascular accident within 6 months prior to the first
dose of study drug

- Subjects with known infection with human immunodeficiency virus (HIV) or Acquired
Immune Deficiency Syndrome (AIDS)

- Subjects with confirmed Hepatitis A, B or C

- Subjects being actively treated for a secondary malignancy or any malignancy within
the last 3 years, with the exception of non-melanomatous skin cancer or localized,
definitively treated cervical cancer. Men under observation for local prostate cancer
are also eligible if they have had stable disease for at least 1 year.

- Uncontrolled or severe cardiovascular disease, including myocardial infarct or
unstable angina within 6 months prior to study treatment, New York Heart Association
(NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring
medication for treatment, clinically significant pericardial disease, or cardiac
amyloidosis

- Known history of malignant hypertension

- Uncontrolled intercurrent illness including symptomatic congestive heart failure,
cardiac arrhythmia, or psychiatric illness/social situations which in the opinion of
the study investigators would be associated with undue risk of participation in the
study

- Use of an investigational drug within 28 days or 5 half-lives prior to first dose.

- Pregnant or breastfeeding
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Raphael Bueno, M.D.
Phone: 617-525-8704
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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