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Onvansertib + NALIRIFOX for Pancreatic Cancer (PANCONVA Trial)
Kansas City, KS
Phase 1 & 2
Recruiting
Led By Anup Kasi, MD, MPH
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* No previous systemic therapy in the metastatic setting
* Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial focuses on pancreatic cancer, a deadly disease that will be the second leading cause of cancer-related death in 2030. Current standard treatments for advanced pancreatic cancer include NALIRIFOX,
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Who is the study for?
This trial is for adults (18+) with advanced pancreatic cancer that hasn't spread and who haven't had treatment yet. They need to be able to understand the study, agree in writing, and have measurable disease by RECIST 1.1 standards. Participants must also provide tissue samples and have a good performance status (ECOG 0/1), along with specific blood cell count levels.Check my eligibility
What is being tested?
The trial tests Onvansertib, an oral drug targeting PLK1 proteins involved in tumor growth, combined with NALIRIFOX therapy. It aims to improve survival rates for patients with KRAS-mutated pancreatic cancer where current treatments are limited.See study design
What are the potential side effects?
Specific side effects of Onvansertib aren't listed here but may include typical reactions from anticancer drugs such as nausea, fatigue, blood cell changes leading to increased infection risk or bleeding problems, liver issues, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had systemic therapy for cancer that has spread.
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My cancer is a type of pancreatic cancer confirmed by lab tests.
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My cancer is advanced and cannot be removed by surgery, and I haven't received any treatment yet.
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I am fully active or can carry out light work.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Adverse Events
Anti-tumor activity by Disease Control Rate (DCR)
Anti-tumor activity by Duration of Response (DOR)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
Study Drug: Onvansertib:
Orally daily on D1 - 5 of each 14-day cycle
NALIRIFOX Intravenous D1 of each 14-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onvansertib
2023
Completed Phase 2
~280
Find a Location
Closest Location:The University of Kansas Cancer Center, Westwood Campus· Kansas City, KS· 198 miles
Who is running the clinical trial?
Cardiff OncologyIndustry Sponsor
11 Previous Clinical Trials
629 Total Patients Enrolled
University of Kansas Medical CenterLead Sponsor
522 Previous Clinical Trials
177,765 Total Patients Enrolled
Anup Kasi, MD, MPHPrincipal InvestigatorThe University of Kansas Cancer Center