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.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| KS | The University of Kansas Cancer Center, Westwood Campus | Kansas City66205 | NCT06736717 | Map |
| MD | University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore21201 | NCT05450965 | Map |
| MN | Mayo Clinic in Rochester | Rochester55905 | NCT05549661 | Map |
| OR | OHSU Knight Cancer Institute | Portland97239 | NCT04005690 | Map |
Onvansertib clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | withdrawn | no longer available | Total |
|---|---|---|---|---|---|---|
| Early P1 | 1 | 1 | ||||
| P1 | 1 | 1 | ||||
| P1/P2 | 1 | 1 | 2 | 4 | ||
| P2 | 1 | 1 | 3 | 1 | 6 | |
| N/A | 1 | 1 |
Recruiting Onvansertib clinical trials (4)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT04005690 | Targeted Pathway Inhibition in Patients With Pancreatic Cancer | Early P1 | Locally Advanced Pancreatic Ductal Adenocarcinoma | 90 | Aug 2019 |
| NCT05549661 | Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap Neoplasms | P1 | Recurrent Chronic Myelomonocytic Leukemia | 25 | Apr 2023 |
| NCT05450965 | Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer | P2 | Small-cell Lung Cancer | 37 | Jul 2022 |
| NCT06736717 | PANCONVAOnvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer | P1/P2 | Pancreatic Cancer | 21 | Feb 2025 |
Onvansertib clinical trials by indication
Metastatic Colorectal Cancer (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06106308 | — | P2 | active not recruiting | Study 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 |
| NCT03829410 | — | P1/P2 | completed | Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation |
| NCT04446793 | — | N/A | no longer available | Expanded 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)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04005690 | — | Early P1 | recruiting | Targeted Pathway Inhibition in Patients With Pancreatic Cancer |
| NCT06398587 | — | P2 | withdrawn | Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma |
Pancreatic Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06736717 | PANCONVA | P1/P2 | recruiting | Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer |
Recurrent Chronic Myelomonocytic Leukemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05549661 | — | P1 | recruiting | Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap Neoplasms |
Colorectal Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05593328 | KRAS | P2 | completed | Study 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)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05383196 | — | P1/P2 | active not recruiting | Onvansertib + Paclitaxel In TNBC |
Small-cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05450965 | — | P2 | recruiting | Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer |
Pancreatic Ductal Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04752696 | — | P2 | completed | Onvansertib 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)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03414034 | — | P2 | completed | Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer |
Acute Myeloid Leukemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03303339 | AML | P1/P2 | completed | Onvansertib 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.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| KRAS | NCT05593328 | P2 | completed | Colorectal Cancer | 23 | — |
Terminated and withdrawn Onvansertib trials (1)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT06398587withdrawnOnvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma
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 ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT05383196 | Onvansertib + Paclitaxel In TNBC | P1/P2 | active not recruiting | 50 | Antonio Giordano, MD | Sep 2022 | |
| NCT04005690 | Targeted Pathway Inhibition in Patients With Pancreatic Cancer | Early P1 | recruiting | 90 | OHSU Knight Cancer Institute | Aug 2019 | |
| NCT05549661 | Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MPN Overlap Neoplasms | P1 | recruiting | 25 | Mayo Clinic | Apr 2023 | |
| NCT05450965 | Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer | P2 | recruiting | 37 | University of Maryland, Baltimore | Jul 2022 | |
| NCT06398587 | Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma | P2 | withdrawn | 0 | OHSU Knight Cancer Institute | Aug 2024 | |
| NCT06736717 | PANCONVA | Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer | P1/P2 | recruiting | 21 | University of Kansas Medical Center | Feb 2025 |
| NCT06106308 | Study 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 | P2 | active not recruiting | 110 | Cardiff Oncology | Feb 2024 | |
| NCT04752696 | Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma | P2 | completed | 41 | Cardiff Oncology | May 2021 | |
| NCT05593328 | KRAS | Study 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 | P2 | completed | 23 | Cardiff Oncology | Mar 2023 |
| NCT03829410 | Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation | P1/P2 | completed | 68 | Cardiff Oncology | Jun 2019 | |
| NCT03414034 | Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer | P2 | completed | 72 | Cardiff Oncology | Aug 2018 | |
| NCT03303339 | AML | Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML) | P1/P2 | completed | 72 | Cardiff Oncology | Nov 2017 |
| NCT04446793 | Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer | — | no longer available | 0 | Cardiff 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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