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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non Hematologic Cancers Metastatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VS-4718

Oral VS-4718 administered BID (QD during first cohort) during a 28 day cycle.

Group Type EXPERIMENTAL

VS-4718

Intervention Type DRUG

Interventions

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VS-4718

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No