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

Phase 2
18 Years
Not Enrolling
Malignant Pleural Mesothelioma

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Trial Information

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

Inclusion Criteria:

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

- 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 pemetrexed/cisplatin or pemetrexed/carboplatin therapy
within ≤ 6 weeks of study entry.

- 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

- 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

- 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

- 12 Known history of malignant hypertension.

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Compare the overall survival (OS) in subjects with malignant pleural mesothelioma receiving VS-6063 or placebo

Outcome Description:

The median duration of OS will be estimated based on the 50th percentile of the Kaplan-Meier distribution

Outcome Time Frame:

From randomization to end of life, an expected average of 12 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2013

Completion Date:

December 2016

Related Keywords:

  • Malignant Pleural Mesothelioma
  • Mesothelioma