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

Verastem

Status and phase

Terminated

Phase 1

Conditions

Metastatic Cancer

Non Hematologic Cancers

Treatments

Drug: VS-4718

Study type

Interventional

Funder types

Industry

Identifiers

NCT01849744

VS-4718-101

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.