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VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer

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.
 
ClinicalTrials.gov Identifier: NCT01486329
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Vaximm GmbH

Tracking Information
First Submitted Date  ICMJE December 2, 2011
First Posted Date  ICMJE December 6, 2011
Last Update Posted Date June 8, 2015
Study Start Date  ICMJE December 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
Safety and tolerability [ Time Frame: 38 days ]
Number of dose-limiting toxicities and maximum tolerated dose
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
  • Immune response [ Time Frame: Up to 24 months ]
    Number of immune positive patients
  • Tumor staging [ Time Frame: Up to 24 months ]
    Tumor staging according to RECIST criteria
  • Tumor perfusion [ Time Frame: Up to 24 months ]
    Tumor perfusion determined by DCE-MRI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer
Official Title  ICMJE VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer to Examine Safety, Tolerability, and Immune Response to the Investigational VEGFR-2 DNA Vaccine VXM01
Brief Summary First-in-human phase I dose escalation study in patients with locally advanced, inoperable and stage IV pancreatic cancer to examine safety, tolerability, and immune response to the investigational VEGFR-2 DNA vaccine VXM01 to examine safety and tolerability, clinical and immunogenic response to the investigational vascular endothelial growth factor receptor 2 (VEGFR-2) DNA vaccine VXM01, and to define the maximum tolerated dose.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stage IV Pancreatic Cancer
Intervention  ICMJE
  • Biological: VXM01
    Live anti-angiogenic cancer vaccine drink solution, escalating dose
  • Biological: Placebo
    Drink solution
Study Arms  ICMJE
  • Experimental: VXM01
    Investigational anti-angiogenic live cancer vaccine
    Intervention: Biological: VXM01
  • Placebo Comparator: Placebo
    Placebo control
    Intervention: Biological: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2014)
72
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2011)
37
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent, signed and dated
  • Locally advanced, inoperable and stage IV pancreatic cancer patients according to UICC based on diagnostic imaging using computer-tomography (CT) or histological examinations
  • Male or post-menopausal female
  • Age above or equal to 18 years
  • Chemotherapy naïve within 60 days before screening visit except gemcitabine treatment
  • Karnovsky index >70
  • Life expectancy >3 months
  • Adequate renal, hepatic, and bone marrow function
  • Absolute neutrophil count >1500/µL
  • Hemoglobin >10 g/dL
  • Platelets >75000/µL
  • Prothrombin time and international normalized ratio (INR) <1.5 times upper limit of normal (ULN) (except under anticoagulant treatment)
  • Aspartate aminotransferase <4 times ULN
  • Alanine aminotransferase <4 times ULN
  • Total bilirubin <3 times ULN
  • Creatinine clearance estimated according to Cockcroft-Gault >30 mL/min
  • Proteinuria <1 g protein on 24 h urine collection

Exclusion Criteria:

  • State after pancreas resection (complete or partial)
  • Resectable disease
  • Drug trial participation within 60 days before screening visit
  • Other previous or current malignancy except basal or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for <2 years
  • Prior vaccination with Ty21a
  • Cardiovascular disease defined as:

    • Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
    • Arterial thromboembolic event within 6 months before randomization including:
    • Myocardial infarction
    • Unstable angina pectoris
    • Cerebrovascular accident
    • Transient ischemic attack
  • Congestive heart failure New York Heart Association grade III to IV
  • Serious ventricular arrhythmia requiring medication
  • Clinically significant peripheral artery disease > grade 2b according to Fontaine
  • Hemoptysis within 6 months before randomization
  • Esophageal varices
  • Upper or lower gastrointestinal bleeding within 6 months before randomization
  • Significant traumatic injury within 4 weeks before randomization
  • Non-healing wound, bone fracture or any history of gastrointestinal ulcers within three years before inclusion, or positive gastroscopy within 3 months before inclusion
  • Gastrointestinal fistula
  • Thrombolysis therapy within 4 weeks before randomization
  • Bowel obstruction within the last 30 days before screening visit
  • Liver cirrhosis ≥ grade B according to Child-Pugh Score-Classification
  • Presence of any acute or chronic systemic infection
  • Radiotherapy within 4 weeks before randomization
  • Major surgical procedures, or open biopsy within 4 weeks before randomization
  • Fine needle aspiration within 7 days before randomization
  • Chronic concurrent therapy within 2 weeks before and during the double-blind study period with:

    • Corticosteroids (except steroids for adrenal failure) or immunosuppressive agents
    • Antibiotics
    • Bevacizumab
    • Any epidermal growth factor receptor inhibitor
    • Chemotherapy except gemcitabine before Day 10
  • Multi-drug resistant gram-negative germ
  • Pregnancy
  • Lactation
  • Inability to comply with study and/or follow-up procedures
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the study results or render the patient at high risk for treatment complications
  • Women of childbearing potential
  • Any history of drug hypersensitivity
  • Any condition which results in an undue risk for the patient during the study participation according to the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01486329
Other Study ID Numbers  ICMJE VXM01-01-DE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vaximm GmbH
Study Sponsor  ICMJE Vaximm GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Schmidt, MD University Clinics, Heidelberg
PRS Account Vaximm GmbH
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP