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RECRUITING Phase 1

Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer

NCT06736717 · View on ClinicalTrials.gov ↗

Study Summary

Pancreatic cancer is a deadly disease and will be the second leading cause of cancer related death behind lung cancer by 2030. Over 62,000 people are diagnosed each year in the United States with about 90% succumbing to the disease within 5 years. In the metastatic setting, NALIRIFOX, FOLFIRINOX and nab-paclitaxel-gemcitabine are standard treatment options in patients with good performance status (Eastern Cooperative Oncology Group \[ECOG\] 0/1). All three combinations have shown a survival advantage over previously standard gemcitabine-based therapy, with 11.1 months overall survival (OS) for NALIRIFOX/FOLFIRINOX and 8.7 months for nab-paclitaxel-gemcitabine versus 6.7 months for gemcitabine alone. There is an urgent need to improve treatment of patients with current and emerging therapeutic strategies. KRAS is the most common oncogene mutated in pancreatic adenocarcinoma, and it is mutated in nearly all tumors. Mutant KRAS is essential for PDAC growth, where the constitutive activated RAS proteins contribute to tumorigenesis, treatment resistance, and metastases. Despite research and drug development efforts focused on KRAS, no effective RAS inhibitors have been approved for the treatment of pancreatic cancer with KRAS mutation. The poor prognosis of KRAS-mutated PDAC patients and the absence of KRAS-targeted therapies, highlight the urgency to develop novel therapies aimed at KRAS. This study will investigate onvansertib (also known as PCM-075 and NMS-1286937) as the first PLK1-specific adenosine triphosphate competitive inhibitor administered by oral route to enter clinical trials with proven antitumor activity in different preclinical models.

Conditions Studied

Interventions

  • DRUG NALIRIFOX
  • DRUG Onvansertib

Study Locations (1)

Kansas

  • The University of Kansas Cancer Center, Westwood Campus — Kansas City

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2025-02
Est. Completion 2027-01
Phase Phase 1

Sponsor

University of Kansas Medical Center

454 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06736717

The ClinicalTrials.gov registry entry for NCT06736717 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 454 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions — of which NALIRIFOX is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06736717 reports 1 study location spanning 1 distinct geographic area — top geographies include Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06736717 about?

NCT06736717 is a clinical study titled "Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer". Pancreatic cancer is a deadly disease and will be the second leading cause of cancer related death behind lung cancer by 2030. Over 62,000 people are diagnosed each year in the United States with about 90% succumbing to the disease within 5 years. In the metastatic setting, NALIRIFOX, FOLFIRINOX and...

What is the current status of trial NCT06736717?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2025-02. Estimated completion is 2027-01.

What conditions does trial NCT06736717 study?

This clinical trial studies the following conditions: Pancreatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06736717?

The interventions under investigation include: NALIRIFOX (DRUG), Onvansertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06736717?

This trial is sponsored by University of Kansas Medical Center, which has 454 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06736717 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial