Phase I Dose Escalation Study of VS-4718 in Subjects With Metastatic Non-Hematologic Malignancies

Status:	Active, not recruiting
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	1/13/2017
Start Date:	June 2013
End Date:	December 2017

A Phase I Study of VS-4718, a Focal Adhesion Kinase Inhibitor, in Subjects With Metastatic Non-Hematologic Malignancies

This is a Phase I, open-label, multicenter, dose-escalation trial of VS-4718, a focal
adhesion kinase inhibitor, in subjects with metastatic non-hematologic malignancies. This
clinical study is comprised of 2 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-4718 in your blood) and the anti-cancer activity of
VS-4718. The pharmacodynamic effects (genes or proteins that may predict or show how your
body may respond to VS-4718) will also be examined in tumor biopsies and blood samples.

Inclusion Criteria:

- Age ≥ 18 years.

- Histopathologically confirmed diagnosis of a metastatic non-hematologic malignancy.

- ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2

- Adequate renal function

- Adequate hepatic function (total bilirubin ≤ 1.5x ULN (upper limit of normal) for the
institution; AST [aspartate transaminase] and ALT [alanine transaminase] ≤ 3x ULN, or
≤ 5x ULN if due to liver involvement by tumor).

- Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; unsupported platelets ≥ 100 x10
9 cells/L; absolute neutrophil count ≥ 1.5x10 9 cells/L

- Corrected QT interval (QTc) < 470 ms

- Subjects must have at least one tumor lesion that is suitable for repeat biopsy, and
must agree to two tumor biopsies (pre- and post- treatment).

- Willing and able to participate in the trial and comply with all trial requirements.

Exclusion Criteria:

- Gastrointestinal (GI) condition which could interfere with the swallowing or
absorption of study medication.

- Uncontrolled or severe concurrent medical condition (including uncontrolled brain
metastases).

- History of upper gastrointestinal bleeding, ulceration, or perforation within 12
months.

- Known history of stroke or cerebrovascular accident within 6 months.

- Subjects being actively treated for a secondary malignancy.

We found this trial at

sites

Sarah Cannon Research Institute

3322 West End Avenue
Nashville, Tennessee 37203

(615)329-SCRI (7274)