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NCT02004028 · REGISTRY CONDITION SEARCH

Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2024-02-20

This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery) study in subjects with malignant pleural mesothelioma who are eligible for surgery. Subjects will receive VS-6063 (defactinib) 400 mg twice daily for 12, 21, or 35 days or 100 mg formulation twice daily for 21 days. Pre- and post-treatment biopsies and blood samples will be collected. The purpose of this study is to assess biomarker responses from tumor tissue. The safety, pharmacokinetics, and tumor response rate to VS-6063 (defactinib) will be also be assessed.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of pFAK Inhibition in Tumor Tissue

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outcome · POSTED

Evaluate the Pharmacokinetics of VS-6063 (Defactinib), CMax

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outcome · POSTED

Evaluate the Pharmacokinetics of VS-6063 (Defactinib), AUC (Area Under the Curve)

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outcome · POSTED

Evaluate the Pharmacokinetics of VS-6063 (Defactinib), Median Tmax (h)

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outcome · POSTED

Number of Patients With at Least One Adverse Event

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outcome · POSTED

To Evaluate the Tumor Response to VS-6063 (Defactinib)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed malignant pleural mesothelioma that is not metastatic or unresectable * Eligible to undergo excisional surgery such as pleurectomy/decortication (P/DC) or any other mesothelioma surgery. * Localized disease. The malignancy is confined to one affected hemithorax. Mediastinal N2 lymph nodes via cervical mediastinoscopy or EBUS (endobronchial ultrasound) must be negative in order to be eligible * Grossly normal pulmonary, cardiac function, renal, hepatic hematologic and performance functions * Male or non-pregnant female * Age ≥ 18 years of age * Tissue is required prior to enrollment. If patient was diagnosed outside and tumor tissue is not available, a pleural biopsy for frozen tissue collection is required. Exclusion Criteria: * Participants who have had chemotherapy or radiotherapy any time prior to entering the study or at any prior time for mesothelioma. Patients receiving chemotherapy type drugs for benign conditions can participate in this trial * 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 or any current hyperbilirubinemia of any cause * 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) * Subjects with confirmed Hepatitis A, B or C * Subjects being actively treated for a secondary malignancy or any malignancy within the last 3 years, with the exception of non-melanomatous skin cancer or localized, definitively treated cervical cancer. Men under observation for local prostate cancer are also eligible if they have had stable disease for at least 1 year. * 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 * Known history of malignant hypertension * Uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations which in the opinion of the study investigators would be associated with undue risk of participation in the study * Use of an investigational drug within 28 days or 5 half-lives prior to first dose. * Pregnant or breastfeeding
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Administered orally (BID) for 12, 21 or 35 days (+/- 2 days)
    intervention Names
    1. Drug: VS-6063
    label
    VS-6063 (defactinib)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. VS-6063 (defactinib)
    name
    VS-6063
    other Names
    1. defactinib
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
35
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    percentage VS-6063 (defactinib)
    measure
    Percentage of pFAK Inhibition in Tumor Tissue
    time Frame
    Cohort 1, From Baseline to Day 12; Cohort 2, From Baseline to Day 35; Cohorts 3, From Baseline to Day 21; Cohorts 3, From Baseline to day 21 day.
  2. description
    Maximum observed plasma concentration
    measure
    Evaluate the Pharmacokinetics of VS-6063 (Defactinib), CMax
    time Frame
    0-24 hours
  3. description
    Area under plasma Concentration (AUC) 0 to t
    measure
    Evaluate the Pharmacokinetics of VS-6063 (Defactinib), AUC (Area Under the Curve)
    time Frame
    0-8 hours
  4. description
    Time to Maximum concentration (Tmax)
    measure
    Evaluate the Pharmacokinetics of VS-6063 (Defactinib), Median Tmax (h)
    time Frame
    0-24 hours
secondary Outcomes
  1. description
    Adverse events will be graded by the CTCAE (Common Terminology Criteria for Adverse Events) 4.0 and summarized according to the worst grade observed since the first treatment dose.
    measure
    Number of Patients With at Least One Adverse Event
    time Frame
    Cohort 1, 40 days; Cohort 2, 42 days; Cohort 3, 28 days; Cohort 4, 28 days.
  2. description
    Modified RECIST criteria for assessment of response in malignant pleural mesothelioma Ann Oncol 2004. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the in the volume of target lesions; Progressive Disease (PD) at least a 20% increase in the volume of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter.
    measure
    To Evaluate the Tumor Response to VS-6063 (Defactinib)
    time Frame
    Cohort 1, 40 days; Cohort 2, 42 days; Cohort 3, 28 days; Cohort 4, 28 days.
Full study description
brief Summary
This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery) study in subjects with malignant pleural mesothelioma who are eligible for surgery. Subjects will receive VS-6063 (defactinib) 400 mg twice daily for 12, 21, or 35 days or 100 mg formulation twice daily for 21 days. Pre- and post-treatment biopsies and blood samples will be collected. The purpose of this study is to assess biomarker responses from tumor tissue. The safety, pharmacokinetics, and tumor response rate to VS-6063 (defactinib) will be also be assessed.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-4021993a435abea4ec76
      requested nct id
      NCT02004028
      primary nct id
      NCT02004028
      source kind
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      source record id
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      source file sha256
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      payload sha256
      5ac706accee591a4c9c2560665954021a48b27de61b6b863bcfd83640ce7b169
      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-4021993a435abea4ec76
      link basis
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      nct id
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      occurrences
      1. context exact
        NCT02004028
        end
        11
        exact text
        NCT02004028
        start
        0
      offset unit
      unicode_code_points
      query cond
      Malignant Mesothelioma
      query disease state id
      ds-malignant-mesothelioma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-malignant-mesothelioma-000.json
      source file sha256
      0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
      source json pointer
      /studies/20/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      bfbac018b2d00d2a1e8f32a0e0419fa54d6c25177e9f36a1483c644aa1442025

    Preserved source evidence · Not medical advice