Actively Recruiting
Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer
Led by University of Kansas Medical Center · Updated on 2025-02-06
21
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
U
University of Kansas Medical Center
Lead Sponsor
C
Cardiff Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and willing to sign informed consent
- Male or female aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease according to RECIST 1.1 criteria
- Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
- Locally advanced unresectable or metastatic disease, treatment naive
- No prior systemic therapy for metastatic disease
- Willingness to provide archival tissue or undergo fresh biopsy if safe
- Adequate organ function including WBC > 3 K/UL, absolute neutrophil count > 1.5 K/UL, platelets > 100 K/UL, hemoglobin ≥ 9 g/dL without transfusions, creatinine clearance ≥ 50 mL/min, total bilirubin ≤ 1.5 x ULN
- Liver enzymes AST and ALT ≤ 2.5 x ULN unless liver metastases present, then ≤ 5 x ULN
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use contraception or abstain
You will not qualify if you...
- Simultaneous enrollment in another therapeutic clinical trial
- Current or planned use of other anti-cancer or investigational agents
- Psychiatric illness or social situation limiting compliance
- Pregnancy or breastfeeding
- Known allergy to any component of study drugs
- Active Grade 3 or higher infection within 2 weeks before treatment
- Major surgery within 4 weeks prior to enrollment
- Untreated or symptomatic brain metastases
- Gastrointestinal conditions impairing oral drug absorption
- Unable or unwilling to swallow study medication
- Uncontrolled illnesses such as active infection, non-healing wounds, symptomatic heart failure Class II or higher, unstable angina, arrhythmia, or significant pulmonary disease
- Active HIV with measurable viral load or active hepatitis B or C infection
- Symptomatic COVID-19 infection
- Clinically significant ascites or pleural effusions
- History of other malignancies except certain treated cancers with no recurrence for over 2 years
- Any condition making treatment unsafe or compliance unlikely
- Use of prohibited medications affecting QT interval or interacting with study drugs
- QTcF interval over 470 milliseconds or risk factors for torsade de pointes
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States, 66205
Actively Recruiting
Research Team
K
KUCC Navigation
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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