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Non Small Cell Lung CancerPhase 2NCT01951690

Phase II Study of VS-6063 in Patients With KRAS Mutant Non-Small Cell Lung Cancer

A Phase 2 study testing defactinib (VS-6063) in people with Non Small Cell Lung Cancer and Lung Cancer, run by Verastem, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase II, open-label, multicenter, multi cohort, study of VS-6063 (defactinib), a focal adhesion kinase inhibitor, in patients with KRAS mutant non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer, Lung Cancer
What is being tested?
defactinib (VS-6063)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
9 sitesUnited States
Study dates
Sep 2013to Jun 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years of age.
  • ECOG (Eastern Cooperative Oncology Group) Performance Score of 0 or 1.
  • Histologic or cytologic confirmation of non-small cell lung cancer (NSCLC)
  • Molecular characterization of the tumor demonstrating a KRAS mutation by a CLIA-certified assay. Adequate archival tissue, tissue core biopsy specimen, or DNA samples must be available for central testing of INK4a/Arf and p53 if not previously performed by a CLIA certified lab.
  • Documented evidence of distant metastasis or locoregional recurrence per required assessments within 28 days prior to starting study therapy.
  • Note: Histologic confirmation of metastatic disease is not required.
Show all 14Show fewer
  • For patients with brain metastases, the following criteria must be met:
  • Previously untreated brain metastases that are asymptomatic and not requiring steroids are permitted.
  • Previously treated brain metastases are permitted if most recent CNS radiographic imaging demonstrates no evidence of CNS disease progression For patients with previously untreated brain metastases, Central Nervous System (CNS) imaging is required at the time of disease imaging throughout treatment.
  • At least one measurable disease site per RECIST v1.1.
  • Received a minimum of one course of treatment that included at least one platinum-based chemotherapy doublet for metastatic or locally recurrent disease.
  • Adequate hematologic function including ANC ≥ 1200/mm3, Hemoglobin ≥ 9 g/dL (transfusion is permitted), and platelets ≥ 100,000/mm3.
  • Adequate hepatic function including ALT ≤ 2.5 x upper limit of normal (ULN) if liver metastasis is NOT present or ≤ 5 x ULN if liver metastasis is present, and total bilirubin ≤ 1.5 x ULN.
  • QTc (corrected QT) interval < 480 msec.

Who cannot join

  • Presence of an activating EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinase) translocation in the tumor.
  • Radiotherapy (RT) completed within 14 days prior to the first dose of study therapy.
  • Known impairment of gastrointestinal function that would alter drug absorption.
  • Leptomeningeal metastasis.
  • Symptomatic or untreated brain metastases or spinal cord compression or any of these conditions requiring chronic steroids to control symptoms.
  • History or evidence of cardiac risk
  • Known history of malignant hypertension (severe hypertension >180/120 mmHg with end organ involvement.
  • Another active concurrent malignancy.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8852

  • University of Colorado Cancer Center, Anschutz Medical Campus

    Denver, Colorado, 80045

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • University of Pittsburgh Medical Center Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Knight Cancer Institute, Oregon Health and Science University

    Portland, Oregon, 97239

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase II Study of VS-6063, A Focal Adhesion Kinase (FAK) Inhibitor, in Patients With KRAS Mutant Non-Small Cell Lung Cancer

This is a Phase II, open-label, multicenter, multi cohort, study of VS-6063 (defactinib), a focal adhesion kinase inhibitor, in patients with KRAS mutant non-small cell lung cancer (NSCLC). NSCLC with a KRAS mutation is required for study entry and subjects will be enrolled into 1 of 4 cohorts based on the status of their INK4a/Arf and p53 mutations. The purpose of this study is to demonstrate if VS-6063 (defactinib) improves PFS within each cohort. The safety and tolerability of VS-6063, tumor response rate, progression free survival and overall survival will also be assessed. The pharmacodynamic effects of VS-6063 (defactinib) will be examined in a tumor biopsy and a blood sample.

Read the detailed description

Eleven subjects will be enrolled into one of four cohorts: Cohort A (KRAS mutation, wild type INK4a/ARF and wildtype p53), Cohort B (KRAS mutation, INK4s/ARF mutation and wild type p53), Cohort C (KRAS mutation, wild type INK4a/ARF and p53 mutation), and Cohort D (KRAS mutation, INK4a/ARF mutation and p53 mutation). If >/= 4 patients demonstrate PFS at 12 weeks in each cohort, an additional 23 subjects will be enrolled.

Being tested
defactinib (VS-6063)
Keywords
Focal Adhesion Kinase inhibitor, FAK inhibitor, Cancer Stem Cells, CSC, KRAS mutation
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • defactinib (VS-6063)Drug

Study groups in NCT01951690
Study groupRoleWhat they receive
VS-6063 (defactinib)ExperimentalAdministered orally BID in a 21 day cycle
Receives: Drug: defactinib (VS-6063)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demonstrate that VS-6063 (defactinib), will improve PFS at 12 weeks (PFS12) within each cohort.

    Measured: From baseline through 12 weeks of treatment

Secondary outcomes (3)

  1. Evaluate the response rate (RR)

    RR is measured as the best overall response using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1.

    Measured: Every 6 weeks from baseline through the end of treatment, an expected average of 4 months

  2. Evaluate progression free survival

    PFS will be estimated in each cohort using Kaplan-Meier product limit estimates.

    Measured: From the date of first treatment to the date of progression including death from any cause, expected average at least 4 months

  3. Evaluate Overall Survival (OS)

    OS in each cohort will be estimated using Kaplan-Meier product limit estimates.

    Measured: OS will be calculated from the date of first treatment to the date of death from any cause, expected average of at least 12 months. Patients who did not experience death will be censored at the last follow-up time.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01951690
Sponsor's protocol ID
VS-6063-201
Status last verified
Apr 2017
First submitted
23 Sep 2013
Last updated
13 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Shimizu T, Fukuoka K, Takeda M, Iwasa T, Yoshida T, Horobin J, Keegan M, Vaickus L, Chavan A, Padval M, Nakagawa K. A first-in-Asian phase 1 study to evaluate safety, pharmacokinetics and clinical activity of VS-6063, a focal adhesion kinase (FAK) inhibitor in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 May;77(5):997-1003. doi: 10.1007/s00280-016-3010-1. Epub 2016 Mar 30.

    PubMed 27025608

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing defactinib (VS-6063) in people with Non Small Cell Lung Cancer and Lung Cancer, run by Verastem, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demonstrate that VS-6063 (defactinib), will improve PFS at 12 weeks (PFS12) within each cohort. (time frame: From baseline through 12 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01951690, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.

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