VXM01 phase I dose escalation study in patients with locally advanced, inoperable and stage IV pancreatic cancer

Phase 1

Completed

• Conditions: ocally advanced, inoperable and stage IV pancreatic cancer; Cancer; Malignant neoplasm of pancreas

• Registration Number: ISRCTN68809279
• Lead Sponsor: VAXIMM GmbH (Germany)

Brief Summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22906006 2. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26137397 (added 21/01/2019) 3. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29632710 (added 21/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-12
• Study Completion: 2014-12-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

1. State after pancreas resection (complete or partial)
2. Resectable disease
3. Drug trial participation within 60 days before screening visit
4. 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
5. Prior vaccination with Ty21a
6. Cardiovascular disease defined as:
6.1. Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
6.2. Arterial thromboembolic event within 6 months before randomization including:
6.2.1. Myocardial infarction
6.2.2. Unstable angina pectoris
6.2.3. Cerebrovascular accident
6.2.4 Transient ischemic attack
7. Congestive heart failure New York Heart Association grade III to IV
8. Serious ventricular arrhythmia requiring medication
9. Clinically significant peripheral artery disease > grade 2b according to Fontaine
10. Hemoptysis within 6 months before randomization
11. Esophageal varices
12. Upper or lower gastrointestinal bleeding within 6 months before randomization
13. Significant traumatic injury within 4 weeks before randomization
14. Non-healing wound, bone fracture or any history of gastrointestinal ulcers within three years before inclusion, or positive gastroscopy within 3 months before inclusion
15. Gastrointestinal fistula
16. Thrombolysis therapy within 4 weeks before randomization
17. Bowel obstruction within the last 30 days before screening visit
18. Liver cirrhosis = grade B according to Child-Pugh Score-Classification
19. Presence of any acute or chronic systemic infection
20. Radiotherapy within 4 weeks before randomization
21. Major surgical procedures, or open biopsy within 4 weeks before randomization
22. Fine needle aspiration within 7 days before randomization
23. Chronic concurrent therapy within 2 weeks before and during the double-blind study period with:
23.1. Corticosteroids (except steroids for adrenal failure) or immunosuppressive agents
23.2. Antibiotics
23.3. Bevacizumab
23.4. Any epidermal growth factor receptor inhibitor
23.5. Chemotherapy except gemcitabine before day 10
24. Multi-drug resistant gram-negative germ
25. Pregnancy
26. Lactation
27. Inability to comply with study and/or follow-up procedures
28. 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
29. Women of childbearing potential
30. Any history of drug hypersensitivity
31. Any condition which results in an undue risk for the patient during the study participation according to the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified