Onvansertib

Generic Name: Onvansertib

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₇F_₃N_₈O_₃

CAS Number: 1034616-18-6

Unique Ingredient Identifier: 67RM91WDHQ

Background: Onvansertib is under investigation in clinical trial NCT03303339 (Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML).).

Clinical Trials

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

Phase 1

Recruiting

Conditions: Pancreatic Cancer

Interventions: Drug: Onvansertib
Drug: NALIRIFOX

First Posted Date: 2024-12-17

Last Posted Date: 2025-02-06

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 21

Registration Number: NCT06736717

Locations: 🇺🇸
The University of Kansas Cancer Center, Westwood Campus, Kansas City, Kansas, United States

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

Phase 2

Withdrawn

Conditions: Locally Advanced Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Ductal Adenocarcinoma
Stage II Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8
Unresectable Pancreatic Adenocarcinoma

Interventions: Drug: Onvansertib
Drug: Gemcitabine
Drug: Nab-paclitaxel
Procedure: Electrocardiography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Procedure: Biospecimen Collection
Procedure: Computed Tomography

First Posted Date: 2024-05-03

Last Posted Date: 2024-07-19

Lead Sponsor: OHSU Knight Cancer Institute

Registration Number: NCT06398587

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

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

Phase 2

Active, not recruiting

Conditions: CRC
Metastatic Colorectal Cancer
KRAS/NRAS Mutation

Interventions: Drug: Onvansertib
Drug: FOLFIRI
Drug: Bevacizumab
Drug: FOLFOX

First Posted Date: 2023-10-30

Last Posted Date: 2025-04-29

Lead Sponsor: Cardiff Oncology

Target Recruit Count: 113

Registration Number: NCT06106308

Locations: 🇺🇸
Mayo Clinic - Arizona, Phoenix, Arizona, United States
🇺🇸
The University of Arizona Cancer Center, Tucson, Arizona, United States
🇺🇸
St. Bernards Medical Center, Jonesboro, Arkansas, United States

and more 38 locations

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

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer
Colorectal Cancer

Interventions: Drug: Onvansertib
Drug: FOLFIRI
Drug: Bevacizumab

First Posted Date: 2022-10-25

Last Posted Date: 2025-01-10

Lead Sponsor: Cardiff Oncology

Target Recruit Count: 23

Registration Number: NCT05593328

Locations: 🇺🇸
San Juan Oncology Associates, Farmington, New Mexico, United States
🇺🇸
Pacific Cancer Medical Center, Anaheim, California, United States
🇺🇸
Washington University School of Medicine Center for Advanced Medicine, Saint Louis, Missouri, United States

and more 24 locations

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

Phase 1

Recruiting

Conditions: Recurrent Chronic Myelomonocytic Leukemia
Refractory Chronic Myelomonocytic Leukemia
Recurrent Atypical Chronic Myeloid Leukemia
Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified
Recurrent Myelodysplastic/Myeloproliferative Neoplasm
Refractory Myelodysplastic/Myeloproliferative Neoplasm

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration and Biopsy
Drug: Onvansertib
Procedure: Ultrasound Imaging

First Posted Date: 2022-09-22

Last Posted Date: 2025-02-14

Lead Sponsor: Mayo Clinic

Target Recruit Count: 25

Registration Number: NCT05549661

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

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

Phase 2

Recruiting

Conditions: Small-cell Lung Cancer
Small Cell Lung Carcinoma

Interventions: Drug: Onvansertib

First Posted Date: 2022-07-11

Last Posted Date: 2024-11-01

Lead Sponsor: Taofeek Owonikoko

Target Recruit Count: 37

Registration Number: NCT05450965

Locations: 🇺🇸
University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Onvansertib + Paclitaxel In TNBC

Phase 1

Active, not recruiting

Conditions: Hormone Receptor/Growth Factor Receptor-Negative Breast Cancer
HER2-negative Breast Cancer
Hormone Receptor Negative Breast Carcinoma
Breast Cancer
Unresectable Breast Carcinoma
Locally Advanced Breast Cancer
Metastatic Breast Cancer
Invasive Breast Cancer
Triple Negative Breast Cancer (TNBC)
Inflammatory Breast Cancer

Interventions: Drug: Onvansertib
Drug: Paclitaxel

First Posted Date: 2022-05-20

Last Posted Date: 2025-03-12

Lead Sponsor: Antonio Giordano, MD

Target Recruit Count: 50

Registration Number: NCT05383196

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconness Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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

Phase 2

Completed

Conditions: Pancreatic Ductal Adenocarcinoma

Interventions: Drug: Onvansertib
Drug: Nanoliposomal irinotecan
Drug: Leucovorin
Drug: Fluorouracil

First Posted Date: 2021-02-12

Last Posted Date: 2025-01-07

Lead Sponsor: Cardiff Oncology

Target Recruit Count: 43

Registration Number: NCT04752696

Locations: 🇺🇸
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
🇺🇸
Inova Schar Cancer Institute, Fairfax, Virginia, United States
🇺🇸
Mayo Clinic Rochester, Rochester, Minnesota, United States

and more 3 locations

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

Conditions: Metastatic Colorectal Cancer
KRAS Gene Mutation

First Posted Date: 2020-06-25

Last Posted Date: 2024-02-12

Lead Sponsor: Cardiff Oncology

Registration Number: NCT04446793

Targeted Pathway Inhibition in Patients With Pancreatic Cancer

Early Phase 1

Recruiting

Conditions: Locally Advanced Pancreatic Ductal Adenocarcinoma
Stage II Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Metastatic Pancreatic Ductal Adenocarcinoma
Stage III Pancreatic Cancer AJCC v8
Unresectable Pancreatic Ductal Adenocarcinoma
Borderline Resectable Pancreatic Ductal Adenocarcinoma
Resectable Pancreatic Ductal Adenocarcinoma

Interventions: Drug: Olaparib
Drug: Cobimetinib
Drug: Onvansertib
Drug: Azenosertib
Biological: Tremelimumab
Drug: Saruparib

First Posted Date: 2019-07-02

Last Posted Date: 2025-02-13

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 90

Registration Number: NCT04005690

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

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