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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06736717
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Onvansertib — DRUG
    20 or30mg flat dose - depending on results from safety lead-in. Administered concurrently with NALIRIFOX. Once daily on D1-5 of each 14-day cycle.
  • NALIRIFOX — DRUG
    Chemotherapy regimen of nanoliposomal irinotecan, oxaliplatin, fluorouracil \[5-FU\], and leucovorin. Intravenously on Day 1 of each 14-day cycle.

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Feb 2025
Primary completion
Jul 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Study Drug: Onvansertib: Orally daily on D1 - 5 of each 14-day cycle NALIRIFOX Intravenous D1 of each 14-day cycle

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Approximately 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Kansas Cancer Center, Westwood CampusKansas CityKansas66205-

Find similar trials in Kansas City, KS

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
The University of Kansas Cancer Center, Westwood Campus· Kansas City, KS

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