Onvansertib with NALIRIFOX for Advanced Pancreatic Cancer
This study is testing a new combination treatment for advanced pancreatic cancer. It combines a drug called Onvansertib with a standard chemotherapy regimen called NALIRIFOX. Researchers want to see how many patients respond to this treatment. You might be able to join if you are at least 18 years old, have advanced pancreatic cancer that can be measured, and have a good performance status (meaning you can mostly care for yourself). The study plans to enroll 21 participants. The current status of this study is unclear.
- Study design
- This study plans to enroll 21 participants. It is testing a combination of two drugs.
- What's involved
- Onvansertib is given daily for 5 days, and NALIRIFOX is given on Day 1, both every 14 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how well the treatment works for approximately 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06736717
Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of Kansas Medical CenterInvestigator-initiated
~21 participants
Updated 2025-02-06 on ClinicalTrials.gov
What's tested:OnvansertibNALIRIFOX
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over Approximately 2 years
Conditions
Where it's being run
1 sites across 1 statesKansas1
Study leadership
- Anup Kasi, MD, MPH · PRINCIPAL_INVESTIGATOR · The University of Kansas Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Ability of participant to understand this study, and participant willingness to sign a written informed consent. Remote consenting will be allowed on a case-by-case basis, but will not replace in-person visits for labs/physical, etc.
Males and females age ≥ 18 years
ECOG Performance Status 0 - 1
Measurable disease by RECIST 1.1
Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
Locally advanced unresectable or metastatic disease who are treatment naive
No previous systemic therapy in the metastatic setting
Participant must be willing to submit archival tissue if available and sufficient - otherwise fresh biopsy collection will be performed at screening UNLESS it is deemed medically unsafe for the participant. If participant does not have archival tissue and is not able to undergo a fresh biopsy at this time, enrollment will be per the principal investigator's discretion
Adequate organ function, defined as follows:
Leukocytes (White Blood Cell \[WBC\]) \> 3 K/UL
Absolute Neutrophil Count \>1.5K/UL
Platelets \>100K/UL
Hemoglobin ≥ 9 g/dL(level must be maintained without transfusions)
Calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation
Total bilirubin ≤ 1.5 x ULN
If known Gilbert's syndrome then discuss with principal investigator. Email documentation of discussion and approval will be saved and documented for source.
Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
Women of child-bearing potential (WOCBP) and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section.
Exclusion
Simultaneously enrolled in any therapeutic clinical trial
Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
Is pregnant or breastfeeding
Has a known allergic reaction to any excipient contained in the study drug formulation
Active Grade 3 (per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.027) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
Patient has had major surgery within 4 weeks prior to enrollment
Untreated or symptomatic brain metastasis
Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (e.g., intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
Unable or unwilling to swallow study drug
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure (CHF) Class II or higher according to the New York Heart Association (NYHA) Functional Classification, unstable angina pectoris, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection
Known active infection with HIV, with measurable viral titer, and/or active infection with hepatitis B or C (patients who have had a hepatitis B virus immunization are eligible)
Known active infection with SARS-CoV-2 where symptoms are present
Clinically significant ascites or pleural effusions
Patients with a history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or prostate, or other solid tumors curatively treated with no evidence of disease for \> 2 years
Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug per PI discretion.
Any condition (e.g., psychological, geographical, etc.) that does not permit compliance with the protocol
Treatment with any of the drugs listed in section with title; Prohibited or Restricted Concomitant Medications at the time of study treatment initiation. Planned concomitant use of medications known to prolong the QT/QTc interval according to institutional guidelines. Use of strong CYP3A4 or CYP2C19 inhibitors or strong CYP3A4 inducers. Patients currently receiving these agents who can be switched to alternate therapy are not excluded. Inhibitors should be stopped at least 1 week prior to the first dose of protocol therapy and inducers should be stopped at least 2 weeks prior to initiation of protocol therapy
QT interval: Fridericia's correction (QTcF) \> 470 milliseconds.
A single ECG is sufficient. Triplicate may be done per PI discretion. If triplicate ECG completed, the QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation that are readily corrected (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during Screening and that result may be used to determine eligibility
Presence of risk factors for torsade de pointes, including family history of Long QT Syndrome or uncorrected hypokalemia
What this trial measures
- Overall Response Rate (ORR)Approximately 2 years
Imaging RECIST 1.1