6 completed, 3 active not recruiting, 2 recruiting, 1 no longer available. 9 Phase 2, 4 Phase 1, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 5, Active not recruiting 3, Recruiting 1 |
| Phase 1 | 4 | Active not recruiting 2, Completed 2 |
| Early Phase 1 | 1 | Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer Onvansertib, NALIRIFOX - Pancreatic Cancer | Phase 1 / Phase 2 | Active not recruiting | University of Kansas Medical Center | 16 | 2025-02-17 | 2026-09-25 |
| 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 Onvansertib, FOLFIRI, Bevacizumab - Metastatic Colorectal Cancer, CRC | Phase 2 | Active not recruiting | Cardiff Oncology | 110 | 2024-02-27 | 2026-06-16 |
| 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 Onvansertib, FOLFIRI, Bevacizumab - Colorectal Cancer, Metastatic Colorectal Cancer | Phase 2 | Completed | Cardiff Oncology | 23 | 2023-03-17 | 2025-01-10 |
| Onvansertib + Paclitaxel In TNBC Onvansertib, Paclitaxel - Breast Cancer, Invasive Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | Antonio Giordano, MD | 50 | 2022-09-30 | 2026-02-11 |
| Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer Onvansertib - Small-cell Lung Cancer, Small Cell Lung Carcinoma | Phase 2 | Recruiting | University of Maryland, Baltimore | 37 | 2022-07-19 | 2025-12-17 |
| Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma Onvansertib, Nanoliposomal irinotecan, Leucovorin - Pancreatic Ductal Adenocarcinoma | Phase 2 | Completed | Cardiff Oncology | 41 | 2021-05-25 | 2025-12-22 |
| Targeted Pathway Inhibition in Patients With Pancreatic Cancer Cobimetinib, Olaparib, Onvansertib - Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma | Early Phase 1 | Recruiting | OHSU Knight Cancer Institute | 90 | 2019-08-01 | 2026-09-04 |
| Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation Onvansertib, Bevacizumab, FOLFIRI - Metastatic Colorectal Cancer, KRAS Gene Mutation | Phase 1 / Phase 2 | Completed | Cardiff Oncology | 68 | 2019-06-24 | 2025-03-04 |
| Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer Onvansertib, Abiraterone, Prednisone - Metastatic Castration-Resistant Prostate Cancer | Phase 2 | Completed | Cardiff Oncology | 72 | 2018-08-14 | 2024-11-07 |
| Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML) Onvansertib, Cytarabine, Decitabine - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Completed | Cardiff Oncology | 72 | 2017-11-17 | 2023-02-27 |
| Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients Lung Cancer, Colorectal Cancer | Completed | Memorial Sloan Kettering Cancer Center | 84 | 2014-07-01 | 2016-09-27 | |
| Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer Onvansertib, Bevacizumab, FOLFIRI - Metastatic Colorectal Cancer, KRAS Gene Mutation | No longer available | Cardiff Oncology | 2024-02-12 |
Colorectal Neoplasms (5) · Lung Neoplasms (2) · Pancreatic Neoplasms (2) · Breast Neoplasms (1) · Inflammatory Breast Neoplasms (1) · Leukemia, Myeloid, Acute (1) · Small Cell Lung Carcinoma (1) · Triple Negative Breast Neoplasms (1)
onvansertib (11) · Bevacizumab (4) · IFL protocol (4) · AZD5305 (1) · Antigens (1) · Cytarabine (1) · Decitabine (1) · Disulfides (1) · Fluorouracil (1) · Folfox protocol (1) · Immunoglobulin G (1) · Leucovorin (1) · Paclitaxel (1) · Prednisone (1) · abiraterone (1)
United States (11)
Antonio C Giordano, MD, PhD (1) · Anup Kasi, MD, MPH (1) · Charles D Lopez (1) · Helena Yu, MD (1) · Taofeek Owonikoko, MD, PhD (1)
PMID 34646387, PMID 39475591, PMID 38231047, PMID 39941812
R01CA273216 (1)