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

NCT01486329 | Completed Phase 1 DMC

• 1 other identifier: VXM01-01-DE
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Pancreatic Cancer

Keywords

Pancreatic cancer; Cancer vaccine; Gemcitabine; Inoperable; Gemcitabine chemotherapy; Locally advanced

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Number of dose-limiting toxicities and maximum tolerated dose

  38 days

Secondary Outcomes (3)

• Immune response

  Up to 24 months

• Tumor staging

  Up to 24 months

• Tumor perfusion

  Up to 24 months

Study Arms (2)

VXM01

EXPERIMENTAL

Investigational anti-angiogenic live cancer vaccine

Biological: VXM01

Placebo

PLACEBO COMPARATOR

Placebo control

Biological: Placebo

Interventions

VXM01 BIOLOGICAL

Live anti-angiogenic cancer vaccine drink solution, escalating dose

VXM01

Placebo BIOLOGICAL

Drink solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vaximm GmbH: lead

Study Sites (1)

Clinic of General Surgery

Heidelberg, 69120, Germany

Location

Related Publications (2)

• 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.

  PMID: 26459812 DERIVED

• 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.

  PMID: 22906006 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Thomas Schmidt, MD

  University Clinics, Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 6, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

DE (1)