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Stage IV Pancreatic CancerPhase 1NCT01486329

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

A Phase 1 study testing VXM01 in people with Stage IV Pancreatic Cancer, run by Vaximm GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage IV Pancreatic Cancer
What is being tested?
VXM01
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteGermany
Study dates
Dec 2011to Dec 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Clinic of General Surgery

    Heidelberg, 69120

Other trials in Germany

About this study

Official title: 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.

Being tested
VXM01, Placebo
Keywords
Pancreatic cancer, Cancer vaccine, Gemcitabine, Inoperable, Gemcitabine chemotherapy, Locally advanced
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VXM01Biological

    Live anti-angiogenic cancer vaccine drink solution, escalating dose

  • PlaceboBiological

    Drink solution

Study groups in NCT01486329
Study groupRoleWhat they receive
VXM01ExperimentalInvestigational anti-angiogenic live cancer vaccine
Receives: Biological: VXM01
PlaceboPlacebo comparatorPlacebo control
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability

    Number of dose-limiting toxicities and maximum tolerated dose

    Measured: 38 days

Secondary outcomes (3)

  1. Immune response

    Number of immune positive patients

    Measured: Up to 24 months

  2. Tumor staging

    Tumor staging according to RECIST criteria

    Measured: Up to 24 months

  3. Tumor perfusion

    Tumor perfusion determined by DCE-MRI

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionOct 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01486329
Sponsor's protocol ID
VXM01-01-DE
Status last verified
Jun 2015
First submitted
2 Dec 2011
Last updated
8 Jun 2015
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 26459812

  • 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.

    PubMed 22906006

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VXM01 in people with Stage IV Pancreatic Cancer, run by Vaximm GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: 38 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01486329, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.

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