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Study of VGX-100 Administered Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01514123
Recruitment Status : Active, not recruiting
First Posted : January 20, 2012
Last Update Posted : July 25, 2017
Information provided by (Responsible Party):
Circadian Technologies Ltd.

Brief Summary:
This is a non-randomized, multi-dose, first-in-human, multicenter, two arm (Arm A: VGX-100 alone; Arm B: VGX-100 co-administered with bevacizumab), open label, dose escalation study in subjects with advanced or metastatic solid tumors. The study is aimed at evaluating the safety and establishing the recommended dose of the VEGF-C human monoclonal antibody VGX-100 when administered alone or in combination with bevacizumab.

Condition or disease Intervention/treatment Phase
Neoplasms Cancer Drug: VGX-100 Drug: Bevacizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Dose Escalation Study of the VEGF-C Human Monoclonal Antibody VGX-100 Administered by Intravenous Infusion Alone and Co-administered With Bevacizumab in Adult Subjects With Advanced or Metastatic Solid Tumors
Study Start Date : January 2012
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm A - VGX-100 alone
Dose escalation of VGX-100 monotherapy
Drug: VGX-100
VGX-100 will be administered by IV infusion once every week
Experimental: Arm B - VGX-100 plus bevacizumab
Dose escalation of VGX-100 in combination with escalating doses of bevacizumab
Drug: VGX-100
VGX-100 will be administered by IV infusion once every week
Drug: Bevacizumab
Bevacizumab will be administered by IV infusion once every 2 weeks
Other Name: Avastin

Primary Outcome Measures :
  1. The incidence and severity of adverse events including dose limiting toxicities [ Time Frame: Approximately 16 months ]

Secondary Outcome Measures :
  1. Tumor response by RECIST criteria [ Time Frame: Approximately 16 months ]
    Tumor response assessment will be measured by computated tomography (CT) or Magnetic resonance imaging (MRI) every 8 or 12 weeks throughout the study

  2. Pharmacokinetic parameters of VGX-100 alone and co-administered with bevacizumab including Cmax, Cmin, AUC and if feasible half life (t1/2) [ Time Frame: 28 days after the last subject in each cohort ]
  3. Anti-VGX-100 antibody formation [ Time Frame: Approximately 16 months ]
  4. Biomarker levels including VEGF-A, VEGF-C, VEGF-D, soluble VEGFR-2, and soluble VEGFR-3 [ Time Frame: Approximately 16 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18 years
  • Provision of written informed consent
  • Histologically or cytologically documented advanced or metastatic solid tumor that is refractory to standard treatment, for which no standard therapy is available, or for which the subject refuses standard therapy
  • Life expectancy > 3 months in the opinion of the investigator
  • ECOG performance status 0 to 1
  • Evaluable OR measurable disease by RECIST 1.1 criteria
  • Agree to the use of effective contraceptive if either male or female of child bearing potential

Exclusion Criteria:

  • Inadequate venous access
  • Women who are lactating/breastfeeding
  • Women with a positive pregnancy test or who are planning to become pregnant during the duration of the study
  • Known to be HIV positive, or have chronic hepatitis B or C
  • Major surgical procedure within 6 weeks of Baseline or surgical or other wound that is not fully healed at Baseline
  • Untreated or symptomatic brain metastasis, known central nervous system metastasis, or spinal cord compression (except glioblastoma multiforme)
  • Mediastinal or cavitated, or lung mass located near, invading or encasing a major blood vessel or airway on imaging
  • Squamous cell lung cancer
  • History of or known/suspected gastrointestinal perforation
  • Hemoptysis of >2.5 mL (half a teaspoon) red blood within 28 days of Screening
  • Deep venous thrombosis or history of symptomatic pulmonary thromboembolism within 6 months of Screening
  • Gastrointestinal bleeding requiring medical intervention within 28 days of Screening
  • Receipt of therapeutic concentrations of warfarin or other anticoagulants within 7 days of Screening
  • Receipt of investigational agent(s) for any indication within 28 days of Baseline or 5 half lives, whichever is greater
  • Receipt of the following treatments:

    • Traditional cytotoxics, tyrosine kinase inhibitors or other small molecule anti-cancer agents within 21 days
    • Nitrosoureas, mitomycin C, bevacizumab or trastuzumab within 6 weeks
    • Any other therapeutic monoclonal antibodies within 21 days
    • Hormonal therapy (other than gonadal suppression) within 14 days
  • Radiotherapy:

    • to >25% bone marrow
    • to brain within 28 days of baseline
    • other than above within 14 days of baseline
  • Unstable angina, myocardial infarction, transient ischemic events, or stroke within 24 weeks of Screening
  • History of CNS hemorrhage, cerebrovascular hemorrhage, myocardial infarction or reversible posterior leukoencephalopathy syndrome associated with prior anti-VEGF/anti-VEGFR therapy
  • Uncontrolled hypertension of ≥ CTCAE Grade 2
  • Proteinuria at Baseline of ≥2+ or 1.0g/24 hours
  • Prior allergic reaction to a monoclonal antibody

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01514123

United States, California
UCLA Hematology-Oncology
Santa Monica, California, United States, 90404
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Circadian Technologies Ltd.
Study Director: Clinical Research Circadian Technologies

Responsible Party: Circadian Technologies Ltd. Identifier: NCT01514123     History of Changes
Other Study ID Numbers: VGX-100-1001
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Circadian Technologies Ltd.:
Dose Escalation
Advanced Solid Tumors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Pharmacologic Actions
Antibodies, Monoclonal
Phase 1
Advanced malignancy

Additional relevant MeSH terms:
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents