MedDataX Logo

Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy

NCT ID: NCT02749331

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. Secondary objectives include to evaluate the anti-tumoral efficacy of AdVince infusions on metastatic neuroendocrine tumors, to determine the replication profile of AdVince and to determine the humoral (antibody) and cytokine-mediated immune response to AdVince. Minimum 12 and maximum 35 patients will be included, the number is based on the toxicity observed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuroendocrine Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AdVince

Dose escalation, minimum 3 patients per dose in Phase I. Dose levels:

1. 10 000 000 000 virus particles
2. 100 000 000 000 virus particles
3. 300 000 000 000 virus particles
4. 1000 000 000 000 virus particles

Maximum tolerated dose will be confirmed by 12 additional patients treated at this dose level in Phase IIa.

Group Type EXPERIMENTAL

AdVince

Intervention Type DRUG

Virus solution for infusion in intrahepatic artery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AdVince

Virus solution for infusion in intrahepatic artery

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ad5PeptideTransductionDomain(PTD)(CgA-E1AmiR122)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joakim Crona, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Endocrine Oncology Clinic, Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-000614-64

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VIRUSNET201401

Identifier Type: -

Identifier Source: org_study_id