Phase I/Ib Study of Paclitaxel in Combination With VS-6063 in Patients With Advanced Ovarian Cancer
Completed
Verastem, Inc.
Phase 1
This is a Phase I/Ib, open-label, multicenter, dose-escalation trial of paclitaxel in
combination with defactinib (VS-6063), a focal adhesion kinase inhibitor, in patients with
advanced ovarian cancer. This clinical study is comprised of 2 parts: Phase I (Dose
Escalation) and Phase Ib (Expansion). The purpose of this study is to assess assess the
safety (including the recommended phase 2 dose), the pharmacokinetics, and the anti-cancer
activity of defactinib (VS-6063) when administered in combination with paclitaxel.
Pharmacodynamic effects will also be examined in tumor biopsies.
Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma
Terminated
Verastem, Inc.
Phase 2
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.
Phase I Dose Escalation Study of VS-6063 in Japanese Subjects With Non-Hematologic Malignancies
Completed
Verastem, Inc.
Phase 1
This is a phase I, open-label, dose-escalation trial of defactinib (VS-6063), a focal
adhesion kinase inhibitor, in Japanese patients with non-hematologic malignancies. The
purpose of this study is to assess the safety (including the recommended phase 2 dose), the
pharmacokinetics, and the anti-cancer activity of defactinib (VS-6063).
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
