Onvansertib

DRUG13 trials

Sponsors

Cardiff Oncology, OHSU Knight Cancer Institute, Antonio Giordano, MD, University of Maryland, Baltimore, Mayo Clinic

Conditions

Acute Myeloid LeukemiaBorderline Resectable Pancreatic Ductal AdenocarcinomaBreast CancerCRCColorectal CancerHER2-negative Breast CancerHormone Receptor Negative Breast CarcinomaHormone Receptor/Growth Factor Receptor-Negative Breast Cancer

Early Phase 1

Targeted Pathway Inhibition in Patients With Pancreatic Cancer

RecruitingNCT04005690

OHSU Knight Cancer InstituteBorderline Resectable Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma +5

Start: 2019-08-01End: 2028-02-01Target: 90Updated: 2026-02-27

Phase 1

Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)

CompletedNCT03303339

Cardiff OncologyAcute Myeloid Leukemia

Start: 2017-11-17End: 2021-11-17Updated: 2023-02-27

Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation

CompletedNCT03829410

Cardiff OncologyKRAS Gene Mutation, Metastatic Colorectal Cancer

Start: 2019-06-24End: 2024-01-29Updated: 2025-03-04

Onvansertib + Paclitaxel In TNBC

Active, not recruitingNCT05383196

Antonio Giordano, MDBreast Cancer, HER2-negative Breast Cancer, Hormone Receptor/Growth Factor Receptor-Negative Breast Cancer +7

Start: 2022-09-30End: 2029-02-15Target: 50Updated: 2026-02-11

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

RecruitingNCT05549661

Mayo ClinicMyelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified, Recurrent Atypical Chronic Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia +3

Start: 2023-04-04End: 2027-12-01Target: 25Updated: 2026-02-23

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

RecruitingNCT06736717

University of Kansas Medical CenterPancreatic Cancer

Start: 2025-02-28End: 2027-01-31Target: 21Updated: 2025-02-06

Phase 2

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

CompletedNCT03414034

Cardiff OncologyMetastatic Castration-Resistant Prostate Cancer

Start: 2018-08-14End: 2023-10-16Updated: 2024-11-07

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

CompletedNCT04752696

Cardiff OncologyPancreatic Ductal Adenocarcinoma

Start: 2021-05-25End: 2024-12-24Updated: 2025-12-22

Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

RecruitingNCT05450965

University of Maryland, BaltimoreSmall-cell Lung Cancer, Small Cell Lung Carcinoma

Start: 2022-07-19End: 2027-11-30Target: 37Updated: 2025-12-17

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

CompletedNCT05593328

Cardiff OncologyColorectal Cancer, Metastatic Colorectal Cancer

Start: 2023-03-17End: 2024-12-09Updated: 2025-01-10

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

Active, not recruitingNCT06106308

Cardiff OncologyCRC, KRAS/NRAS Mutation, Metastatic Colorectal Cancer

Start: 2024-02-27End: 2027-01-31Updated: 2026-01-12

Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma

WithdrawnNCT06398587

OHSU Knight Cancer InstituteLocally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8 +3

Start: 2024-08-01End: 2027-06-07Updated: 2024-07-19

Unknown Phase

Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer

Cardiff OncologyKRAS Gene Mutation, Metastatic Colorectal Cancer

Updated: 2024-02-12

Related Papers

MC210807: Phase 1 clinical trial assessing the safety and efficacy of onvansertib, a novel, oral, PLK1 inhibitor in Relapsed/Refractory myeloproliferative chronic myelomonocytic leukemia (CMML).

Blood2025-11-03

Abstract P2-07-26: Onvansertib shows synergistic efficacy in combination with paclitaxel in HR+ breast cancer: Mechanistic insights from preclinical models

Clinical Cancer Research2025-06-13

A phase 1b study of Plk1 inhibitor onvansertib in combination with paclitaxel in metastatic triple-negative breast cancer (mTNBC) patients.

Journal of Clinical Oncology2025-05-281 citations

A phase 1b/2 trial of onvansertib in combination with NALIRIFOX for first line treatment of advanced pancreatic cancer (PANCONVA trial).

Journal of Clinical Oncology2025-05-28

Polo-like Kinase 1 Inhibitors Demonstrate In Vitro and In Vivo Efficacy in Preclinical Models of Small Cell Lung Cancer

Cancers2025-01-282 citations

Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of <i>KRAS</i> -Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial

Journal of Clinical Oncology2024-10-3018 citations

Abstract PO1-04-14: PLK1 Inhibitor Onvansertib Extends the Response and Overcomes Resistance to Paclitaxel in Palbociclib-resistant HR+ Breast Cancer Patient-derived Xenografts

Cancer Research2024-05-02

Abstract CT275: A phase 2, randomized, open-label study of onvansertib in combination with standard-of-care (SoC) versus SoC alone for first-line treatment of RAS-mutant metastatic colorectal cancer (mCRC)

Cancer Research2024-04-05

Abstract 606: The PLK1 inhibitor, onvansertib, synergizes with paclitaxel in small cell lung cancer

Cancer Research2024-03-221 citations

Abstract 2031: A phase 1b/2 clinical study of onvansertib in combination with FOLFIRI/bevacizumab revealed a new role of PLK1 in regulating the hypoxia pathway in KRAS-mutant colorectal cancer

Cancer Research2024-03-22

Abstract B003: Advancing biomarker discovery using a novel window of opportunity (WOO) trial for pancreatic ductal adenocarcinoma: Trial updates

Cancer Research2024-01-16

Phase 1 study to determine the safety and efficacy of onvansertib, a novel, oral, PLK1 inhibitor in patients with proliferative chronic myelomonocytic leukemia relapsed/refractory or intolerant to available therapies.

Journal of Clinical Oncology2023-06-011 citations

A window of opportunity trial for metastatic (WOO-M) pancreatic ductal adenocarcinoma (PDAC): A biomarker discovery platform.

Journal of Clinical Oncology2023-01-242 citations

Plk1 Inhibitors and Abiraterone Synergistically Disrupt Mitosis and Kill Cancer Cells of Disparate Origin Independently of Androgen Receptor Signaling

Cancer Research2022-11-2120 citations

Abstract 1236: Biomarkers of response to abiraterone and the polo-like kinase 1 (PLK1) inhibitor onvansertib in metastatic castration resistant prostate cancer (mCRPC) patients

Cancer Research2022-06-15

A phase 2 study of onvansertib in combination with abiraterone and prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC).

Journal of Clinical Oncology2022-02-163 citations

A phase 1b/2 trial of the PLK1 inhibitor onvansertib in combination with FOLFIRI-bev in 2L treatment of KRAS-mutated (mKRAS) metastatic colorectal carcinoma (mCRC).

Journal of Clinical Oncology2022-01-198 citations

Predictive Biomarkers of Response to the Polo-like Kinase 1 (PLK1) Inhibitor, Onvansertib, in Combination with Decitabine in Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)

Blood2021-11-051 citations

Abstract 425: Expanded access program of the PLK1 inhibitor onvansertib for treatment of patients with KRAS-mutant metastatic colorectal cancer

Cancer Research2021-07-01

Abstract 973: The selective polo-like kinase (Plk1) inhibitor onvansertib and the antiandrogen abiraterone synergistically kill cancer cells through disruption of mitosis independently of androgen receptor signaling

Cancer Research2021-07-01

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