Relapsed Malignant Mesothelioma Clinical Trial
Official title:
A Phase 1 Dose Escalation Study of VS-5584, a Dual PI3K/mTOR Inhibitor, Administered With a Fixed Dose of VS-6063, a Focal Adhesion Kinase Inhibitor, in Subjects With Relapsed Malignant Mesothelioma
The purpose of this study is to evaluate rising dose levels of VS-5584 administered in combination with a fixed dose of VS-6063 in subjects with relapsed malignant mesothelioma to determine a recommended Phase 2 dose (RP2D) for further development of this combination in this indication.
This study is comprised of 2 sequential parts: Part 1 (Dose Escalation of VS-5584) and Part
2 (Expansion). Up to 56 evaluable subjects (i.e., subjects who complete at least 1 cycle [21
days] of therapy) will be enrolled, assuming that:
- Up to 6 dose levels of VS-5584 are studied in Part 1 (Dose Escalation of VS-5584) in
combination with a fixed dose of VS-6063 at 400 mg twice daily (BID) with a maximum of
6 subjects enrolled per VS-5584 dose level, for a total of up to 36 subjects (exclusive
of replacement subjects).
- Up to an additional 20 evaluable subjects may be enrolled in Part 2, the expansion
portion of the study. Subjects will be treated with VS-5584 at the RP2D and schedule
determined in the dose escalation portion of the study in combination with a fixed dose
of VS-6063.
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