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A Phase I/Ib Study of Paclitaxel in Combination With VS-6063, a Focal Adhesion Kinase Inhibitor, in Subjects With Advanced Ovarian Cancer

Phase 1
18 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

A Phase I/Ib Study of Paclitaxel in Combination With VS-6063, a Focal Adhesion Kinase Inhibitor, in Subjects With Advanced Ovarian Cancer

Inclusion Criteria:

1. Able to provide signed and dated informed consent prior to initiation of any study

2. Female subjects aged ≥ 18 years.

3. Advanced or refractory ovarian cancer, confirmed histologically.

4. Subjects may have received up to 4 prior lines of chemotherapy for their metastatic

5. All persistent clinically significant toxicities from prior chemotherapy must be ≤
Grade 1.

6. ECOG performance status of 0 or 1 (refer to Appendix A), measured within 72 hours
before the start of treatment.

7. Predicted life expectancy of ≥ 3 months.

8. Adequate renal function [creatinine ≤ 1.5x ULN (upper limit of normal)] or GFR of ≥

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

10. Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; platelets≥ 100 x109cells/L;
absolute neutrophil count ≥ 1.5x109 cells/L).

11. Corrected QT interval (QTc) < 470 ms (as calculated by the Fridericia correction

12. Negative pregnancy test for females of child-bearing potential; must be surgically
sterile, postmenopausal, or willing and able to be compliant with a contraceptive
regimen (double barrier birth control) during and for 3 months after the treatment

13. Subjects enrolled in the Phase Ib must have at least 1 tumor lesion that is suitable
for repeat biopsy.

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

Exclusion Criteria:

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

2. Uncontrolled or severe concurrent medical condition (including uncontrolled brain
metastases). Stable brain metastases either treated or being treated with a stable
dose of steroids/anticonvulsants, with no dose change within 28 days prior to the
first dose of study drug, will be allowed.

3. History of upper gastrointestinal bleeding, ulceration, or perforation within 12
months prior to the first dose of study drug.

4. Known history of Gilbert's Syndrome.

5. Known history of stroke or cerebrovascular accident within 6 months prior to the
first dose of study drug.

6. Subjects with known infection with human immunodeficiency virus (HIV) or Acquired
Immune Deficiency Syndrome (AIDS) (testing not required).

7. Subjects with Hepatitis A, B or C (testing not required).

8. Subjects being actively treated for a secondary malignancy.

9. Cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or
immunotherapy, etc.) within 28 days of the first dose of study drug or 5 half-lives,
whichever is shorter.

10. Major surgery within 28 days prior to the first dose of study drug.

11. Use of an investigational drug within 28 days or 5 half-lives (whichever is shorter)
prior to the first dose of study drug. A minimum of 10 days between termination of
the investigational drug and administration of the study treatment is required. In
addition, any drug-related toxicity except alopecia should have recovered to grade 1
or less.

12. Pregnant or breastfeeding.

13. Any evidence of serious active infections.

14. Uncontrolled or severe cardiovascular disease, including myocardial infarct or
unstable angina within 6 months prior to study treatment, New York Heart Association
(NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring
medication for treatment, clinically significant pericardial disease, or cardiac

15. Uncontrolled intercurrent illness including symptomatic congestive heart failure,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements.

Type of Study:


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-6063 when administered in combination with paclitaxel in subjects with advanced ovarian tumors

Outcome Description:

Adverse events and their frequency, duration and severity, physical examination, laboratory parameters, vital signs and ECG change monitoring as determined based on CTCAE (Common Toxicity Criteria for Adverse Effects) 4.03

Outcome Time Frame:

From start of treatment to end of treatment, an expected average of 12 weeks

Safety Issue:


Principal Investigator

Mitchell Keegan, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Verastem, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms



Florida Cancer Specialists Fort Myers, Florida  33901
University of Oklahoma Oklahoma City, Oklahoma  73190
Sarah Cannon Research Institute Nashville, Tennessee  37203