NCT02749331Active, not recruitingPhase 1/2
Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy
Study of Recombinant Adenovirus (AdVince) in Patients With Neuroendocrine Tumors; Safety and Efficacy
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 11 Mar 2016
- Start date
- 1 Mar 2016
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Uppsala University
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT02749331
- EU CT number
- 2024-517654-10-00
- EudraCT number
- 2014-000614-64
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 35
- From 1 Mar 2016 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any viral syndrome diagnosed within the previous 2 weeks
- Chemotherapy within the previous 4 weeks Before the first treatment
- Radiotherapy to the target tumor site within the last 24 weeks from the baseline CT scan
- Concomitant malignancy
- Prior participation in any research protocol that involved administration of adenovirus vectors
- Treatment with any other investigational therapy within the last 4 weeks, organ transplantation prior to treatment, severe cardiovascular, metabolic or pulmonary disease
- Continuing treatment with any other cancer therapy
Other illness
- Known chronic liver dysfunction Before the development of metastatic cancer (e.g. cirrhosis, chronic hepatitis)
- Active infection, including documented HIV and hepatitis C
Other
- Pregnant or lactating females
Who the study is looking for
- Subject´s written informed consent
- 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
- Cancer that is not considered resectable for potential cure or tumor reduction
- Patent portal vein and adequate liver perfusion
- Liver dominant disease with involvement of \<60% of liver parenchyma
- Karnofsky performance status of \>=70%
- Life expectancy of \>=6 months
- \>=18 years of age
- Must use a reliable method of contraception if sexually active and of reproductive potential
- Plasma creatinine \<105 ug/ml
- Aspartate transaminase (AST), Alanine transaminase (ALT) and Alkaline Phosphatase (ALP) \<3.0-fold upper limit of normal
- Total bilirubin \<2.0-fold upper limit of normal
- Prothrombin time (PT)/International Normalized Ratio (INR) \<2.0 and Prothromboplastin time (PTT) within normal limits
- Neutrophils \>1500/ml, hemoglobin \>100 g/L, platelets \>100 000/ml
- Patients with functioning NET should have cover by somatostatin analog
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.