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Antimetabolite

Onvansertib + Chemotherapy for Pancreatic Cancer

Phase 2
Waitlist Available
Research Sponsored by Cardiff Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have adequate organ and bone marrow function
Has measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat pancreatic cancer.

Who is the study for?
Adults with metastatic pancreatic ductal adenocarcinoma who've had one prior gemcitabine-based chemotherapy can join. They must have measurable disease, be in good physical condition (ECOG 0-1), and agree to use contraception. Exclusions include pregnancy, recent major surgery or therapy, serious infections or medical conditions, certain heart risks, and previous treatments with irinotecan or similar drugs.Check my eligibility
What is being tested?
The trial tests the effectiveness of onvansertib combined with nanoliposomal irinotecan, leucovorin, and fluorouracil in treating metastatic pancreatic cancer. Participants will receive this combination to see if it improves their condition compared to standard treatments.See study design
What are the potential side effects?
Possible side effects may include reactions from the infusion process itself; gastrointestinal issues like diarrhea; low blood counts leading to increased infection risk; fatigue; liver enzyme changes; and potential for bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs and bone marrow are working well.
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I have a tumor that can be measured with a scan.
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I am fully active or can carry out light work.
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My pancreatic cancer has spread and was confirmed by a lab test.
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I am 18 years old or older.
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My blood clotting time is normal or I'm on warfarin.
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I've had one round of gemcitabine-based chemotherapy for my metastatic disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment Period: Onvansertib + nal-IRI + leucovorin + 5-FUExperimental Treatment4 Interventions
Participants will be administered onvansertib at the dosing schedule selected based on the results of the safety lead-in, in cycles of 2 weeks. Onvansertib will be administered in combination with 70 mg/m^2 nanoliposomal irinotecan (nal-IRI), 400 mg/m^2 leucovorin and 2400 mg/m^2 fluorouracil (5-FU).
Group II: Safety Lead-in: Onvansertib + nal-IRI + leucovorin + 5-FUExperimental Treatment4 Interventions
The first 3 participants will be administered onvansertib orally once a day at a dosing schedule of 12 mg/m^2 on Day 1 to Day 10 for two cycles, where each cycle is 2 weeks. Depending on the number of dose limiting toxicities (DLTs) experienced in the first 3 participants, additional participants may receive different dosing schedules, determining the dosing schedule to be used in the treatment period. Onvansertib will be administered in combination with 70 mg/m^2 nanoliposomal irinotecan (nal-IRI), 400 mg/m^2 leucovorin and 2400 mg/m^2 fluorouracil (5-FU).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
2005
Completed Phase 4
~5730
Fluorouracil
2014
Completed Phase 3
~11540
Onvansertib
2017
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Cardiff OncologyLead Sponsor
10 Previous Clinical Trials
576 Total Patients Enrolled

Media Library

Fluorouracil (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT04752696 — Phase 2
Pancreatic Cancer Research Study Groups: Safety Lead-in: Onvansertib + nal-IRI + leucovorin + 5-FU, Treatment Period: Onvansertib + nal-IRI + leucovorin + 5-FU
Pancreatic Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT04752696 — Phase 2
Fluorouracil (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752696 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the magnitude of the experiment's cohort?

"Affirmative. Per the information available on clinicaltrials.gov, this clinical trial is currently seeking participants; it was first posted on May 3rd 2021 and updated most recently on June 16th 2022. 40 individuals are being recruited from 6 different locations for participation in this study."

Answered by AI

Could you provide a synopsis of the trials conducted with Nanoliposomal irinotecan?

"As of now, 507 clinical trials are researching the efficacy of Nanoliposomal irinotecan. Of those live studies, 143 are in Phase 3 and they span 24422 locations with a majority in Shanghai City."

Answered by AI

Is Nanoliposomal irinotecan a safe treatment for patients?

"There is some evidence suggesting Nanoliposomal irinotecan's safety, warranting a score of 2 on our 1 to 3 scale. However, no data exists regarding its efficacy yet."

Answered by AI

What maladies commonly respond to treatment with Nanoliposomal irinotecan?

"Nanoliposomal irinotecan is frequently recommended to treat rectal carcinoma, as well as colorectal carcinoma, ovarian cancer and sarcoma."

Answered by AI

In which locations has this clinical trial been established?

"There are 6 centres across the United States that have been approved to participate in this trial, including Mayo Clinic Phoenix in Arizona and University of Nebraska Medical Center in Omaha. Additional locations include Inova Schar Cancer Institute located near Fairfax as well as 3 other medical sites."

Answered by AI

Are there any opportunities to join this research study at the present time?

"Affirmative. The clinical trial, which was initially uploaded on May 3 2021 and revised lastly on June 16 2022, is actively recruiting participants from 6 different sites with 40 patients needed for enrolment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma
2021. "Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04752696.
~10 spots leftby Apr 2025
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