Phase I/Ib Study of Paclitaxel in Combination With VS-6063 in Patients With Advanced Ovarian Cancer

Completed · Phase 1

Conditions studied: Ovarian Cancer

In brief

This is a Phase I/Ib, open-label, multicenter, dose-escalation trial of paclitaxel in combination with defactinib (VS-6063), a focal adhesion kinase inhibitor, in patients with advanced ovarian cancer. This clinical study is comprised of 2 parts: Phase I (Dose Escalation) and Phase Ib (Expansion). The purpose of this study is to assess assess the safety (including the recommended phase 2 dose), the pharmacokinetics, and the anti-cancer activity of defactinib (VS-6063) when administered in combination with paclitaxel. Pharmacodynamic effects will also be examined in tumor biopsies.

Key facts

Study ID

NCT01778803

Run by

Verastem, Inc.

People needed

22

Starts

2013-02-26

Expected to finish

2015-02-23

Last updated by the study team

2017-05-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide signed and dated informed consent prior to initiation of any study procedures.
• Female subjects aged ≥ 18 years.
• Advanced or refractory ovarian cancer, confirmed histologically.
• Subjects may have received up to 4 prior lines of chemotherapy for their metastatic disease.
• All persistent clinically significant toxicities from prior chemotherapy must be ≤ Grade 1.
• ECOG performance status of 0 or 1 (refer to Appendix A), measured within 72 hours before the start of treatment.
• Predicted life expectancy of ≥ 3 months.
• Adequate renal function [creatinine ≤ 1.5x ULN (upper limit of normal)] or GFR of ≥ 50mL/min.
• 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).
• Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; platelets≥ 100 x109cells/L; absolute neutrophil count ≥ 1.5x109 cells/L).
• Corrected QT interval (QTc) < 470 ms (as calculated by the Fridericia correction formula).
• 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 period.
• Willing and able to participate in the trial and comply with all trial requirements.

You may not qualify if…

• Gastrointestinal (GI) condition which could interfere with the swallowing or absorption of study medication.
• 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.
• History of upper gastrointestinal bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug.
• Known history of Gilbert's Syndrome.
• Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug.
• Subjects with known infection with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) (testing not required).
• Subjects with Hepatitis A, B or C (testing not required).
• Subjects being actively treated for a secondary malignancy.
• 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.
• Major surgery within 28 days prior to the first dose of study drug.
• 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.
• Pregnant or breastfeeding.
• Any evidence of serious active infections.
• 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 amyloidosis.
• Uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Where it is running

• Florida Cancer Specialists — Sarasota, Florida, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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