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

This study is currently recruiting participants.
Verified February 2014 by Vaximm GmbH
Sponsor:
Information provided by (Responsible Party):
Vaximm GmbH
ClinicalTrials.gov Identifier:
NCT01486329
First received: December 2, 2011
Last updated: February 4, 2014
Last verified: February 2014

December 2, 2011
February 4, 2014
December 2011
October 2014   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 38 days ] [ Designated as safety issue: Yes ]
Number of dose-limiting toxicities and maximum tolerated dose
Same as current
Complete list of historical versions of study NCT01486329 on ClinicalTrials.gov Archive Site
  • Immune response [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Number of immune positive patients
  • Tumor staging [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Tumor staging according to RECIST criteria
  • Tumor perfusion [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Tumor perfusion determined by DCE-MRI
Same as current
Not Provided
Not Provided
 
VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stage IV Pancreatic Cancer
  • Biological: VXM01
    Live anti-angiogenic cancer vaccine drink solution, escalating dose
  • Biological: Placebo
    Drink solution
  • Experimental: VXM01
    Investigational anti-angiogenic live cancer vaccine
    Intervention: Biological: VXM01
  • Placebo Comparator: Placebo
    Placebo control
    Intervention: Biological: Placebo
Niethammer AG, Lubenau H, Mikus G, Knebel P, Hohmann N, Leowardi C, Beckhove P, Akhisaroglu M, Ge Y, Springer M, Grenacher L, Buchler MW, Koch M, Weitz J, Haefeli WE, Schmitz-Winnenthal FH. Double-blind, placebo-controlled first in human study to investigate an oral vaccine aimed to elicit an immune reaction against the VEGF-Receptor 2 in patients with stage IV and locally advanced pancreatic cancer. BMC Cancer. 2012 Aug 20;12:361. doi: 10.1186/1471-2407-12-361.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
December 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Friedrich H Schmitz-Winnenthal, MD +49 6221 566986 ksc@med.uni-heidelberg.de
Germany
 
NCT01486329
VXM01-01-DE
Yes
Vaximm GmbH
Vaximm GmbH
Not Provided
Principal Investigator: Friedrich H Schmitz-Winnenthal, MD University Clinics, Heidelberg
Vaximm GmbH
February 2014

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