Clinical Trials in Sweden / NCT02749331
Active, not recruiting
Phase 1/2
Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy
NCT02749331 · tracked via the Priya Life Science Sweden tracker
Condition(s) studied
Neuroendocrine Tumors
Investigational drug(s) / intervention(s)
AdVince
AdVince: Virus solution for infusion in intrahepatic artery
Study summary
An open-labelled, uncontrolled, single-center Phase I/IIa clinical study to evaluate the safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic neuroendocrine tumors (NETs), and if possible determination of maximum tolerated dose.
Eligibility
Inclusion Criteria:
1. Subject´s written informed consent
2. Histologically and radiologically confirmed progressive neuroendocrine carcinoma of gastrointestinal, pancreatic or bronchial origin with multiple liver metastases. Progression in Clinical symptoms and tumor growth verified over the last 6 months on CT or MRI
3. Cancer that is not considered resectable for potential cure or tumor reduction
4. Patent portal vein and adequate liver perfusion
5. Liver dominant disease with involvement of \<60% of liver parenchyma
6. Karnofsky performance status of \>=70%
7. Life expectancy of \>=6 months
8. \>=18 years of age
9. Must use a reliable method of contraception if sexually active and of reproductive potential
10. Plasma creatinine \<105 ug/ml
11. Aspartate transaminase (AST), Alanine transaminase (ALT) and Alkaline Phosphatase (ALP) \<3.0-fold upper limit of normal
12. Total bilirubin \<2.0-fold upper limit of normal
13. Prothrombin time (PT)/International Normalized Ratio (INR) \<2.0 and Prothromboplastin time (PTT) within normal limits
14. Neutrophils \>1500/ml, hemoglobin \>100 g/L, platelets \>100 000/ml
15. Patients with functioning NET should have cover by somatostatin analog
Exclusion Criteria:
1. Known chronic liver dysfunction Before the development of metastatic cancer (e.g. cirrhosis, chronic hepatitis)
2. Active infection, including documented HIV and hepatitis C
3. Any viral syndrome diagnosed within the previous 2 weeks
4. Chemotherapy within the previous 4 weeks Before the first treatment
5. Radiotherapy to the target tumor site within the last 24 weeks from the baseline CT scan
6. Concomitant malignancy
7. Pregnant or lactating females
8. Prior participation in any research protocol that involved administration of adenovirus vectors
9. Treatment with any other investigational therapy within the last 4 weeks, organ transplantation prior to treatment, severe cardiovascular, metabolic or pulmonary disease
10. Continuing treatment with any other cancer therapy
Primary outcome measure(s)
- Number of Adverse Events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 — From screening visit and through study completion, an average time of 18 months.
AEs probably or possibly related to the study drug or local injuries caused by the administration procedure. If possible identify dose limiting toxicity (DLT), i.e. grade 4 toxicity of any duration or grade 3 toxicity lasting more than 7 days, excluding flu-like symptoms, according to CTCAE v4.03.Clinically significant changes in laboratory parameters (haematology, blood coagulation, liver function, biochemistry and kidney function) and vital signs (body temperature, heart rate, blood pressure, respiratory rate and consciousness according to Reaction Level Scale from 1985 (RLS-85).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Endocrine Oncology Clinic, Uppsala University Hospital | Uppsala | Sweden |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02749331 on ClinicalTrials.gov ↗ ← All trials in Sweden