Phase I Dose Escalation Study of VS-5584 in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma
Status:
Terminated
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR
kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This
clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2
(Expansion). The purpose of this study is to evaluate the safety (including the recommended
Phase II dose), pharmacokinetics (the amount of VS-5584 in subject's blood) and the
anti-cancer activity of VS-5584. Biomarkers (genes or proteins that may predict or show how
subject's body may respond to VS-5584) will also be assessed in archival tumor tissue, tumor
biopsies (in consenting subjects), and blood samples.