A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of VS-6063 in Subjects with Malignant Pleural Mesothelioma.
The purpose of this study is to look at overall survival rate, the rate of disease control, and quality of life in patients with malignant pleural mesothelioma (MPM) receiving either VS-6063 or placebo. A placebo drug is one which does not contain the active ingredient. An additional purpose of this trial is to determine the safety and tolerability of VS-6063 tablets compared to placebo tablets.
Patients must have histologically proven diagnosis of MPM. All patients must have biopsy material (archival tissue is acceptable) available for immunohistochemistry determination of Merlin status prior to enrollment. Patients must have received only one prior chemotherapy regimen consisting of greater than or equal to 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. Patients must have received last dose of pemetrexed/cisplatin or pemetrexed/carboplatin therapy within less than or equal to 6 weeks of study entry. Patients must be greater than or equal to 18 years old, with acceptable lab values and performance score. QTc less than 470 ms. Patients will be excluded if receiving any other investigational agents (or completed within 30 days before study drug administration). Patients will be excluded if they have a GI condition that could interfere with the swallowing or absorption of study drug; history of upper GI bleeding, ulceration, or perforation within 12 months prior to first dose of study drug; uncontrolled or severe concurrent illness including uncontrolled brain metastases; known HIV, Hepatitis A, B, or C; or any evidence of serious active infections. Patients will be excluded if any of the following has occurred within 6 months prior to study entry: stroke or cerebrovascular accident; uncontrolled or severe cardiovascular disease, including myocardial infarction or unstable angina. Patients will be excluded if known history of Gilbertï¿½s Syndrome, malignant hypertension, or 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.
This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study of an oral agent VS-6063 in patients with MPM. Eligible patients will be randomized to VS-6063 or placebo. All patients will need to collect blood specimens, physical examinations, and radiological imaging. Treatment regimen consists of VS-6063 or placebo 400mg twice daily, every day of a 21 day cycle. Treatment will continue until disease progression, unacceptable side effects, study non-compliance, or other reasons.
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