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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Verastem, Inc.
Study ID
NCT01778803
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Feb 26, 2013
Status verified
Jan 2017
Primary completion
Feb 23, 2015
Completion
Feb 23, 2015

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: defactinib (VS-6063) plus paclitaxel
    Oral defactinib (VS-6063) administered twice daily, in combination with intravenous paclitaxel administered on Days 1, 8, and 15 of a 28 day cycle.

Primary Outcome Measure

Number of patients experiencing treatment-related adverse events as assessed by CTCAE v4.03 (Common Toxicity Criteria for Adverse Effects)during the study (safety and tolerability). [ Time Frame: From start of treatment to end of treatment, an expected average of 12 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida--
University of OklahomaOklahoma CityOklahoma--
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Sarasota, FL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Florida Cancer Specialists· Sarasota, FLUniversity of Oklahoma· Oklahoma City, OKSarah Cannon Research Institute· Nashville, TN

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