- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01486329
VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer
June 5, 2015 updated by: Vaximm GmbH
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Heidelberg, Germany, 69120
- Clinic of General Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Placebo control
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Drink solution
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Experimental: VXM01
Investigational anti-angiogenic live cancer vaccine
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Live anti-angiogenic cancer vaccine drink solution, escalating dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: 38 days
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Number of dose-limiting toxicities and maximum tolerated dose
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38 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune response
Time Frame: Up to 24 months
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Number of immune positive patients
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Up to 24 months
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Tumor staging
Time Frame: Up to 24 months
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Tumor staging according to RECIST criteria
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Up to 24 months
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Tumor perfusion
Time Frame: Up to 24 months
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Tumor perfusion determined by DCE-MRI
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Up to 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Schmidt, MD, University Clinics, Heidelberg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wick W, Platten M, Wick A, Hertenstein A, Radbruch A, Bendszus M, Winkler F. Current status and future directions of anti-angiogenic therapy for gliomas. Neuro Oncol. 2016 Mar;18(3):315-28. doi: 10.1093/neuonc/nov180. Epub 2015 Oct 12.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
December 2, 2011
First Submitted That Met QC Criteria
December 5, 2011
First Posted (Estimate)
December 6, 2011
Study Record Updates
Last Update Posted (Estimate)
June 8, 2015
Last Update Submitted That Met QC Criteria
June 5, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VXM01-01-DE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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