Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Kansas Medical Center
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Kansas City
Source: ClinicalTrials.gov · NCT06736717 · last updated 2025-02-06