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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non Hematologic Cancers, Metastatic Cancer

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Trial Information

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


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 [creatinine ≤ 1.5x ULN (upper limit of normal)]

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the safety and tolerability of VS-4718 in subjects with metastatic non-hematologic malignancies

Outcome Description:

Serious Adverse events, Adverse events and their frequency, duration and severity, physical examination, laboratory parameters, vital signs and ECGs as determined based on CTCAE (Common Toxicity Criteria for Adverse Effects) V4.03. A Safety monitoring committee will review safety information.

Outcome Time Frame:

Expected average of 12 weeks from start of treatment to end of treatment

Safety Issue:

Yes

Principal Investigator

Mitchell Keegan, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Verastem, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

VS-4718-101

NCT ID:

NCT01849744

Start Date:

June 2013

Completion Date:

December 2014

Related Keywords:

  • Non Hematologic Cancers
  • Metastatic Cancer
  • Focal Adhesion Kinase inhibitor
  • FAK inhibitor
  • Cancer Stem Cells
  • CSC
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical CenterLos Angeles, California  90048