Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma



Status:Terminated
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2013
End Date:December 2016

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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma

This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of
defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not
progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment
with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the
study, each subject must have tumor Merlin status(high or low) established by
immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1
ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will
be stratified by tumor Merlin status (high versus low). Progression will be assessed both
locally and by central review using the Response Evaluation Criteria In Solid Tumors
(RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression
or other discontinuation criteria are met. Following documentation of nonfatal disease
progression, all subjects will be followed for overall survival by telephone contact every 2
months until end of life or the close of the study.


Inclusion Criteria:

- 1. Able to understand and give written informed consent and comply with study
procedures.

- 2. Histologically proven diagnosis of MPM. All subjects must have biopsy material
(archival tissue is acceptable) available for immunohistochemistry determination of
Merlin status prior to enrollment.

- 3. Evaluable disease, or measurable disease as assessed by RECIST version 1.1.

- 4. Received only one prior chemotherapy regimen consisting of ≥ 4 cycles of
pemetrexed/cisplatin or pemetrexed/carboplatin; subjects must have documentation of
an ongoing response (confirmed PR or SD) following completion of this regimen.
Subjects changing from cisplatin to carboplatin or vice versa within the same course
of treatment because of platinum toxicity will be considered to have had first-line
chemotherapy. Note: Subjects may have undergone previous surgical resection of their
disease providing it was completed prior to initiation of chemotherapy.

- 5. Received last dose of prior chemotherapy within ≤ 6 weeks of first dose of
VS-6063.

- 6. Have completed baseline quality of life evaluation as assessed by LCSS modified
for mesothelioma

- 7. Age ≥18 years.

- 8. Life expectancy ≥3 months.

- 9. All prior cytotoxic toxicities must have resolved to grade ≤ 1 prior to
randomization.

- 10. Performance status according to the Karnofsky Scale of ≥ 70% (after palliative
measures such as pleural drainage).

- 11. Corrected QT interval (QTc) < 470 ms (as calculated by the Fridericia correction
formula).

- 12. Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 109/L;
absolute neutrophil count [ANC] ≥ 1.5 x 109/L) without the use of hematopoietic
growth factors.

- 13. Adequate renal function (creatinine ≤ 1.5 x ULN [upper limit of normal] or
glomerular filtration rate of ≥ 50mL/min).

- 14. Adequate hepatic function (total bilirubin ≤ 1.5 x ULN for the institution;
aspartate transaminase [AST] and alanine transaminase [ALT] ≤ 2.5 x ULN).

- 15. Men and women of childbearing potential must agree to use adequate
contraception(double barrier birth control) for the duration of study therapy and for
3 months after the last dose of VS-6063.

Exclusion Criteria:

- 1. Currently enrolled in (or completed within 30 days before study drug
administration)another investigational drug study.

- 2. GI condition that could interfere with the swallowing or absorption of study drug.

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

- 4. Known history of Gilbert's Syndrome.

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

- 6. Subjects with known infection with human immunodeficiency virus or Acquired Immune
Deficiency Syndrome (testing not required).

- 7. Subjects with known infection with hepatitis A, B or C (testing not required).

- 8. Any evidence of serious active infections.

- 9. Major surgery within 28 days prior to the first dose of study drug.

- 10. Uncontrolled or severe concurrent medical condition (including uncontrolled brain
metastases). Stable brain metastases either previously treated or being treated with
a stable dose of steroids and/or anticonvulsants (no dose change within 28 days prior
to the first dose of study drug) will be allowed.

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

- 12 Known history of malignant hypertension.

- 13. Psychiatric illness or social situations that would limit compliance with study
requirements.

- 14. History of another invasive malignancy in the last 5 years. Adequately treated
noninvasive,non-melanoma skin cancers as well as in situ carcinoma of the cervix
within the last 5 years will be allowed.

- 15. Prior treatment with drugs an FAK inhibitor.

- 16. Women who are pregnant or breastfeeding.
We found this trial at
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Dallas, Texas 75390
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Frankston, Victoria 3199
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19104
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Rochester, Minnesota 55905
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