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Anti-metabolites
Nab-Paclitaxel + Gemcitabine +/- VCN-01 for Pancreatic Cancer (VIRAGE Trial)
Phase 2
Recruiting
Research Sponsored by VCN Biosciences, S.L.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes from baseline to every 8 week or every 4 weeks if there is a suspicion of progressive disease (pd) not radiologically confirmed during treatment and until disease progression up to 3 years.
Awards & highlights
VIRAGE Trial Summary
This trial is testing a new drug combo to treat pancreatic cancer in patients who have advanced disease.
Who is the study for?
This trial is for adults over 18 with stage IV metastatic pancreatic adenocarcinoma who haven't had previous systemic treatment. They should have a measurable tumor, an ECOG performance status of 0 or 1, and adequate organ function. Exclusions include certain genetic syndromes, serious illnesses like active infections or liver disease, prior cancers unless in remission for 3+ years, and pregnant or breastfeeding women.Check my eligibility
What is being tested?
The study is testing the effectiveness of Nab-Paclitaxel and Gemcitabine chemotherapy with or without VCN-01 on patients with metastatic pancreatic cancer. It's a phase IIb trial where participants are randomly assigned to receive either the standard chemo drugs alone or combined with VCN-01.See study design
What are the potential side effects?
Possible side effects may include allergic reactions to medication components, fatigue from chemotherapy treatments, digestive issues such as nausea and vomiting, blood cell count changes leading to increased infection risk or bleeding problems, liver function abnormalities, kidney impairment signs like elevated creatinine levels.
VIRAGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ changes from baseline to every 8 week or every 4 weeks if there is a suspicion of progressive disease (pd) not radiologically confirmed during treatment and until disease progression up to 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes from baseline to every 8 week or every 4 weeks if there is a suspicion of progressive disease (pd) not radiologically confirmed during treatment and until disease progression up to 3 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events after VCN-01 IV administration
Overall Survival
Secondary outcome measures
Changes in tumor marker Ca 19.9
Disease Control Rate (DCR)
Duration of Response (DoR)
+4 moreOther outcome measures
Changes in Quality of Life (QoL) via the validated Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) version 3.
Disease Control Rate (DCR) to subsequent therapies
Immune markers
+5 moreVIRAGE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 -VCN-01 + SoCExperimental Treatment3 Interventions
A maximum of two (2) doses of VCN-01 administrated as a single IV infusion in combination with nab-paclitaxel and gemcitabine as SoC.
Group II: Arm 1-SoCActive Control2 Interventions
Nab-paclitaxel and gemcitabine as SoC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VCN-01
2014
Completed Phase 1
~50
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
VCN Biosciences, S.L.Lead Sponsor
4 Previous Clinical Trials
82 Total Patients Enrolled
Theriva Biologics SLLead Sponsor
4 Previous Clinical Trials
82 Total Patients Enrolled
Carmen Blasco, PhDStudy ChairTheriva Biologics S.L.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a long-term liver condition like cirrhosis or hepatitis.I have had pneumonitis or interstitial lung disease before.I do not have an active infection or serious illness like TB, HBV, HCV, or HIV.I am on or cannot stop anticoagulant therapy around the time of VCN-01 treatment.I am fully active or restricted in physically strenuous activity but can do light work.My organs are functioning well enough for treatment.I have stage IV pancreatic cancer and haven't had treatment yet.I was diagnosed with a viral infection within the last 2 weeks.I am using or willing to use effective birth control or am surgically sterile.I haven't had live vaccines in 3 weeks or the Ad5 COVID vaccine in 12 weeks.My heart's QT interval is longer than normal, and my heart pumps less effectively.I have Li Fraumeni syndrome or a known genetic issue related to retinoblastoma.My recent tests show my organs are functioning well.My doctor recommends a first line treatment other than Gemcitabine/Nab-Paclitaxel.I am not on strong immune system-suppressing drugs, except for low-dose steroids.I have brain metastases but my symptoms are stable.I am currently pregnant or breastfeeding.I have been cancer-free for at least 3 years if I had cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2 -VCN-01 + SoC
- Group 2: Arm 1-SoC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the combination of Arm 2 -VCN-01 and Standard of Care been accepted by the U.S. Food & Drug Administration?
"Our team have given Arm 2 -VCN-01 + SoC a score of two due to the preclinical evidence confirming its safety, but no efficacy data being available yet as this is only in Phase 2."
Answered by AI
Are there any current opportunities to participate in this clinical trial?
"The information on clinicaltrials.gov indicates that patient recruitment for this trial has ceased. Initially posted on October 10th 2023, the last update to the study was made on March 1st of the same year; however, there are currently 777 other studies seeking participants."
Answered by AI
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