Onvansertib Clinical Trials (2026): 13 Studies for Metastatic Colorectal Cancer & Stage III Pancreatic Cancer AJCC v8

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

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13 Onvansertib clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 10 indications (including Metastatic Colorectal Cancer & Stage III Pancreatic Cancer AJCC v8) and 609 total planned enrollment. 4 Onvansertib clinical trials are actively recruiting at 4 U.S. sites across 4 states. Most recent activity: NCT05383196 (Feb 2029).

Where to Participate: All Onvansertib Trial Sites in the U.S. (4 sites across 4 states)

Every actively recruiting Onvansertibtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

StateFacilityCityTrialMap
KSThe University of Kansas Cancer Center, Westwood CampusKansas City66205NCT06736717Map
MDUniversity of Maryland Greenebaum Comprehensive Cancer CenterBaltimore21201NCT05450965Map
MNMayo Clinic in RochesterRochester55905NCT05549661Map
OROHSU Knight Cancer InstitutePortland97239NCT04005690Map

Onvansertib clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletedwithdrawnno longer availableTotal
Early P111
P111
P1/P21124
P211316
N/A11

Recruiting Onvansertib clinical trials (4)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT04005690Targeted Pathway Inhibition in Patients With Pancreatic CancerEarly P1Locally Advanced Pancreatic Ductal Adenocarcinoma90Aug 2019
NCT05549661Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap NeoplasmsP1Recurrent Chronic Myelomonocytic Leukemia25Apr 2023
NCT05450965Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung CancerP2Small-cell Lung Cancer37Jul 2022
NCT06736717PANCONVAOnvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic CancerP1/P2Pancreatic Cancer21Feb 2025

Onvansertib clinical trials by indication

Metastatic Colorectal Cancer (3)

NCTAcronymPhaseStatusTitle
NCT06106308P2active not recruitingStudy of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation
NCT03829410P1/P2completedOnvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation
NCT04446793N/Ano longer availableExpanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer

Locally Advanced Pancreatic Ductal Adenocarcinoma (2)

NCTAcronymPhaseStatusTitle
NCT04005690Early P1recruitingTargeted Pathway Inhibition in Patients With Pancreatic Cancer
NCT06398587P2withdrawnOnvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma

Pancreatic Cancer (1)

NCTAcronymPhaseStatusTitle
NCT06736717PANCONVAP1/P2recruitingOnvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer

Recurrent Chronic Myelomonocytic Leukemia (1)

NCTAcronymPhaseStatusTitle
NCT05549661P1recruitingOnvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap Neoplasms

Colorectal Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05593328KRASP2completedStudy of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation

Breast Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05383196P1/P2active not recruitingOnvansertib + Paclitaxel In TNBC

Small-cell Lung Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05450965P2recruitingStudy of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

Pancreatic Ductal Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT04752696P2completedOnvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma

Metastatic Castration-Resistant Prostate Cancer (1)

NCTAcronymPhaseStatusTitle
NCT03414034P2completedOnvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer

Acute Myeloid Leukemia (1)

NCTAcronymPhaseStatusTitle
NCT03303339AMLP1/P2completedOnvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)

Onvansertib pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
KRASNCT05593328P2completedColorectal Cancer23

Terminated and withdrawn Onvansertib trials (1)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

All Onvansertib trials (13)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT05383196Onvansertib + Paclitaxel In TNBCP1/P2active not recruiting50Antonio Giordano, MDSep 2022
NCT04005690Targeted Pathway Inhibition in Patients With Pancreatic CancerEarly P1recruiting90OHSU Knight Cancer InstituteAug 2019
NCT05549661Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap NeoplasmsP1recruiting25Mayo ClinicApr 2023
NCT05450965Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung CancerP2recruiting37University of Maryland, BaltimoreJul 2022
NCT06398587Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal AdenocarcinomaP2withdrawn0OHSU Knight Cancer InstituteAug 2024
NCT06736717PANCONVAOnvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic CancerP1/P2recruiting21University of Kansas Medical CenterFeb 2025
NCT06106308Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS MutationP2active not recruiting110Cardiff OncologyFeb 2024
NCT04752696Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal AdenocarcinomaP2completed41Cardiff OncologyMay 2021
NCT05593328KRASStudy of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) MutationP2completed23Cardiff OncologyMar 2023
NCT03829410Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS MutationP1/P2completed68Cardiff OncologyJun 2019
NCT03414034Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate CancerP2completed72Cardiff OncologyAug 2018
NCT03303339AMLOnvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)P1/P2completed72Cardiff OncologyNov 2017
NCT04446793Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancerno longer available0Cardiff Oncology

Onvansertib clinical trials: frequently asked questions

How many Onvansertib clinical trials are there?
13 Onvansertib clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 4 are actively recruiting participants. 5 are marked completed.
Are Onvansertib clinical trials recruiting in 2026?
Yes — 4 Onvansertib trials are actively recruiting in 2026, with 4 U.S. sites across 4 states. See the recruiting trials and the per-state site list further down this page.
What conditions is Onvansertib being studied for?
Onvansertib is being studied for Metastatic Colorectal Cancer, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8, KRAS Gene Mutation and 31 more. The trials are grouped by indication on this page.
What phase is Onvansertib in?
Onvansertib clinical trials span 6 Phase 2, 1 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Onvansertib clinical trials?
The lead sponsor across the most Onvansertib trials is Cardiff Oncology, with 5 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Onvansertibas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

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