Onvansertib Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Onvansertib comprises 21 peer-reviewed publications across 15 journals, 0 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Pancreatic Neoplasms, Colorectal Neoplasms, Lung Neoplasms, and Leukemia, Myeloid, Acute. Most recent publication: Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial., J Clin Oncol, 2025.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial.
    Ahn DH, Ridinger M, Cannon TL, et al. · J Clin Oncol · 2025
    PubMed: PMID 39475591 · NCT03829410 · Colorectal Neoplasms
  2. Onvansertib in Combination with FOLFIRI and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Phase Ib Clinical Study.
    Ahn DH, Barzi A, Ridinger M, et al. · Clin Cancer Res · 2024
    PubMed: PMID 38231047 · NCT03829410 · Colorectal Neoplasms
  3. Polo-like Kinase 1 Inhibitors Demonstrate In Vitro and In Vivo Efficacy in Preclinical Models of Small Cell Lung Cancer.
    Zhang G, Pannucci A, Ivanov AA, et al. · Cancers (Basel) · 2025
    PubMed: PMID 39941812 · NCT05450965 · Lung Neoplasms
  4. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy.
    Hagege A, Ambrosetti D, Boyer J, et al. · Theranostics · 2022
    PubMed: PMID 34646387 · NCT03303339 · Leukemia, Myeloid, Acute
  5. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial.
    Wainberg ZA, Melisi D, Macarulla T, et al. · Lancet · 2023
  6. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine.
    Von Hoff DD, Ervin T, Arena FP, et al. · N Engl J Med · 2013
  7. Pancreatic cancer.
    Hidalgo M · N Engl J Med · 2010
  8. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer.
    Conroy T, Desseigne F, Ychou M, et al. · N Engl J Med · 2011

Publications by year

19892025: 21 publications.

1989
1
1999
1
2005
1
2006
1
2009
2
2010
2
2011
1
2012
1
2013
1
2014
1
2015
1
2016
1
2018
1
2019
1
2022
1
2023
1
2024
1
2025
2

Publications by indication

Pancreatic Neoplasms (17)

  • NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial.
    Lancet · 2023 · PMID 37708904 · NCT06736717
  • KRAS: The Critical Driver and Therapeutic Target for Pancreatic Cancer.
    Cold Spring Harb Perspect Med · 2019 · PMID 29229669 · NCT06736717
  • Suppression of KRas-mutant cancer through the combined inhibition of KRAS with PLK1 and ROCK.
    Nat Commun · 2018 · PMID 27193833 · NCT06736717
  • Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update.
    J Clin Oncol · 2016 · PMID 26169616 · NCT06736717
  • Whole genomes redefine the mutational landscape of pancreatic cancer.
    Nature · 2015 · PMID 25719666 · NCT06736717

Colorectal Neoplasms (2)

  • Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial.
    J Clin Oncol · 2025 · PMID 39475591 · NCT03829410
  • Onvansertib in Combination with FOLFIRI and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Phase Ib Clinical Study.
    Clin Cancer Res · 2024 · PMID 38231047 · NCT03829410

Lung Neoplasms (1)

  • Polo-like Kinase 1 Inhibitors Demonstrate In Vitro and In Vivo Efficacy in Preclinical Models of Small Cell Lung Cancer.
    Cancers (Basel) · 2025 · PMID 39941812 · NCT05450965

Leukemia, Myeloid, Acute (1)

  • The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy.
    Theranostics · 2022 · PMID 34646387 · NCT03303339

Publications by journal

All Onvansertib publications (21)

2025 (2 papers)

  1. Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial.
    Ahn DH, Ridinger M, Cannon TL, et al. · J Clin Oncol · 2025 · Trial result
    PubMed: PMID 39475591 · NCT03829410 · Colorectal Neoplasms
  2. Polo-like Kinase 1 Inhibitors Demonstrate In Vitro and In Vivo Efficacy in Preclinical Models of Small Cell Lung Cancer.
    Zhang G, Pannucci A, Ivanov AA, et al. · Cancers (Basel) · 2025 · Derived
    PubMed: PMID 39941812 · NCT05450965 · Lung Neoplasms

2024 (1 paper)

  1. Onvansertib in Combination with FOLFIRI and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Phase Ib Clinical Study.
    Ahn DH, Barzi A, Ridinger M, et al. · Clin Cancer Res · 2024 · Trial result
    PubMed: PMID 38231047 · NCT03829410 · Colorectal Neoplasms

2023 (1 paper)

  1. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial.
    Wainberg ZA, Melisi D, Macarulla T, et al. · Lancet · 2023 · Background

2022 (1 paper)

  1. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy.
    Hagege A, Ambrosetti D, Boyer J, et al. · Theranostics · 2022 · Derived
    PubMed: PMID 34646387 · NCT03303339 · Leukemia, Myeloid, Acute

2019 (1 paper)

  1. KRAS: The Critical Driver and Therapeutic Target for Pancreatic Cancer.
    Waters AM, Der CJ · Cold Spring Harb Perspect Med · 2019 · Background

2018 (1 paper)

  1. Suppression of KRas-mutant cancer through the combined inhibition of KRAS with PLK1 and ROCK.
    Wang J, Hu K, Guo J, et al. · Nat Commun · 2018 · Background

2016 (1 paper)

  1. Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update.
    Smith TJ, Bohlke K, Lyman GH, et al. · J Clin Oncol · 2016 · Background

2015 (1 paper)

  1. Whole genomes redefine the mutational landscape of pancreatic cancer.
    Waddell N, Pajic M, Patch AM, et al. · Nature · 2015 · Background

2014 (1 paper)

  1. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States.
    Rahib L, Smith BD, Aizenberg R, et al. · Cancer Res · 2014 · Background

2013 (1 paper)

  1. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine.
    Von Hoff DD, Ervin T, Arena FP, et al. · N Engl J Med · 2013 · Background

2012 (1 paper)

  1. Pancreatic cancer genomes reveal aberrations in axon guidance pathway genes.
    Biankin AV, Waddell N, Kassahn KS, et al. · Nature · 2012 · Background

2011 (1 paper)

  1. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer.
    Conroy T, Desseigne F, Ychou M, et al. · N Engl J Med · 2011 · Background

2010 (2 papers)

  1. Pancreatic cancer.
    Hidalgo M · N Engl J Med · 2010 · Background
  2. Targeting Polo-like kinase in cancer therapy.
    Degenhardt Y, Lampkin T · Clin Cancer Res · 2010 · Background

2009 (2 papers)

  1. A genome-wide RNAi screen identifies multiple synthetic lethal interactions with the Ras oncogene.
    Luo J, Emanuele MJ, Li D, et al. · Cell · 2009 · Background
  2. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).
    Eisenhauer EA, Therasse P, Bogaerts J, et al. · Eur J Cancer · 2009 · Background

2006 (1 paper)

  1. Polo-like kinase 1 expression is a prognostic factor in human colon cancer.
    Weichert W, Kristiansen G, Schmidt M, et al. · World J Gastroenterol · 2006 · Background

2005 (1 paper)

  1. Polo-like kinase isoforms in breast cancer: expression patterns and prognostic implications.
    Weichert W, Kristiansen G, Winzer KJ, et al. · Virchows Arch · 2005 · Background

1999 (1 paper)

  1. Prognostic significance of polo-like kinase (PLK) expression in squamous cell carcinomas of the head and neck.
    Knecht R, Elez R, Oechler M, et al. · Cancer Res · 1999 · Background

1989 (1 paper)

  1. Optimal two-stage designs for phase II clinical trials.
    Simon R · Control Clin Trials · 1989 · Background
    PubMed: PMID 2702835 · NCT06736717 (PANCONVA) · Pancreatic Neoplasms

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).