Trial Title:
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
NCT ID:
NCT06106308
Condition:
Metastatic Colorectal Cancer
CRC
KRAS/NRAS Mutation
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Onvansertib
Conditions: Keywords:
Metastatic Colorectal Cancer
KRAS Mutation
NRAS Mutation
CRC
First-Line
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Onvansertib
Description:
Oral capsule
Arm group label:
Onvansertib 20 mg + Standard of Care
Arm group label:
Onvansertib 20mg + Standard of Care
Arm group label:
Onvansertib 30 mg + Standard of Care
Arm group label:
Onvansertib 30 mg + Standard of Care (SOC)
Intervention type:
Drug
Intervention name:
FOLFIRI
Description:
FOLFIRI (irinotecan + fluorouracil [5-FU] + leucovorin) as intravenous (IV) infusion
Arm group label:
Onvansertib 20mg + Standard of Care
Arm group label:
Onvansertib 30 mg + Standard of Care (SOC)
Arm group label:
Standard of Care (SOC)
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
IV Infusion
Arm group label:
Onvansertib 20 mg + Standard of Care
Arm group label:
Onvansertib 20mg + Standard of Care
Arm group label:
Onvansertib 30 mg + Standard of Care
Arm group label:
Onvansertib 30 mg + Standard of Care (SOC)
Arm group label:
Standard of Care
Arm group label:
Standard of Care (SOC)
Intervention type:
Drug
Intervention name:
FOLFOX
Description:
FOLFOX (leucovorin + fluorouracil [5-FU] + oxaliplatin) as intravenous (IV) infusion
Arm group label:
Onvansertib 20 mg + Standard of Care
Arm group label:
Onvansertib 30 mg + Standard of Care
Arm group label:
Standard of Care
Summary:
The purpose of this study is to assess 2 different doses of onvansertib to select the
lowest dose that is maximally effective, and to assess the safety, efficacy,
pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI +
bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic
colorectal cancer (CRC) in the first-line setting.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed metastatic colorectal cancer.
- Documented KRAS or NRAS mutation.
- No previous systemic therapy in the metastatic setting.
- Participants must be willing to submit archival tissue or undergo fresh biopsy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Women of childbearing potential must use contraception or take measures to avoid
pregnancy.
- Imaging computed tomography (CT) or magnetic resonance imaging (MRI) of
chest/abdomen/pelvis and other scans as necessary to document all sites of disease
performed within 28 days prior to the first dose of onvansertib.
- Must have acceptable organ function
Exclusion Criteria:
- Concomitant KRAS or NRAS and BRAF-V600 mutation or microsatellite instability
high/deficient mismatch repair.
- Prior treatment with a VEGF inhibitor, including bevacizumab or biosimilars.
- Previous oxaliplatin treatment within 12 months prior to randomization, when arm
open.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Anticancer chemotherapy or biologic therapy administered within 28 days prior to the
first dose of study drug.
- Untreated or symptomatic brain metastasis.
- Gastrointestinal (GI) disorder(s) that would significantly impede the absorption of
an oral agent.
- Unable or unwilling to swallow study drug.
- Uncontrolled intercurrent illness.
- Known hypersensitivity to fluoropyrimidine or leucovorin, irinotecan, or oxalipatin.
- Abnormal glucuronidation of bilirubin; known Gilbert's syndrome.
- Use of strong CYP3A4 or CYP2C19 inhibitors or strong CYP3A4 inducers.
- QTc >470
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic - Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
480-301-8484
Facility:
Name:
The University of Arizona Cancer Center
Address:
City:
Tucson
Zip:
85724
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
520-694-2873
Facility:
Name:
St. Bernards Medical Center
Address:
City:
Jonesboro
Zip:
72401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
870-336-5732
Facility:
Name:
Highlands Oncology Group
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
479-587-1700
Facility:
Name:
Pacific Cancer Medical Center
Address:
City:
Anaheim
Zip:
92801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
714-999-1465
Facility:
Name:
Comprehensive Blood and Cancer Center - Bakersfield
Address:
City:
Bakersfield
Zip:
93309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
661-322-2206
Facility:
Name:
Orange Coast Memorial Medical Center
Address:
City:
Fountain Valley
Zip:
92708
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
657-241-9755
Facility:
Name:
UC San Diego Moores Cancer Center
Address:
City:
La Jolla
Zip:
92037
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
858-534-5555
Facility:
Name:
Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90089
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
323-226-2622
Facility:
Name:
UCLA Department of Medicine-Hematology/Oncology
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
855-731-6040
Facility:
Name:
Sharp Memorial Hospital
Address:
City:
San Diego
Zip:
92123
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
858-939-4030
Facility:
Name:
Torrance Memorial Physician Network - Cancer Care and Infusion Center
Address:
City:
Torrance
Zip:
90505
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
310-750-3300
Facility:
Name:
PIH Health
Address:
City:
Whittier
Zip:
90602
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
562-789-5480
Facility:
Name:
Memorial Cancer Institute
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
924-265-4325
Facility:
Name:
Mayo Clinic - Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
904-953-2200
Facility:
Name:
Cleveland Clinic Martin Health
Address:
City:
Stuart
Zip:
34994
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
772-419-2162
Facility:
Name:
Kaiser Permanente
Address:
City:
Honolulu
Zip:
96819
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
808-432-5555
Phone ext:
1584
Facility:
Name:
Fort Wayne Medical Oncology and Hematology
Address:
City:
Fort Wayne
Zip:
46804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
260-436-0800
Facility:
Name:
The University of Kansas Cancer Center - Westwood
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
913-588-1227
Facility:
Name:
Cancer Center of Kansas
Address:
City:
Wichita
Zip:
67214
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
316-262-4467
Facility:
Name:
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
616-654-5550
Facility:
Name:
Mayo Clinic Cancer Center
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
507-538-3270
Facility:
Name:
Saint Luke's Hospital
Address:
City:
Kansas City
Zip:
64111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
816-932-3300
Facility:
Name:
Washington University School of Medicine Center for Advanced Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
800-600-3606
Facility:
Name:
CCCN
Address:
City:
Las Vegas
Zip:
89119
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
702-952-3400
Phone ext:
11100
Facility:
Name:
Manhattan Hematology Oncology (MHO) Research Foundation, Inc.
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
212-689-6791
Facility:
Name:
Trihealth Kenwood
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
513-865-9460
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
800-641-2422
Facility:
Name:
The Ohio State University Wexner Medical Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
1-800-293-5066
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
503-494-7999
Facility:
Name:
Lehigh Valley Health Network
Address:
City:
Allentown
Zip:
18103
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
610-402-9543
Facility:
Name:
West Cancer Clinic
Address:
City:
Germantown
Zip:
38138
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
901-683-0055
Facility:
Name:
Oncology Consultants, PA
Address:
City:
Houston
Zip:
77024
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
855-827-9525
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
877-632-6789
Facility:
Name:
Utah Cancer Specialists
Address:
City:
Salt Lake City
Zip:
84124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
801-281-6864
Facility:
Name:
University of Virginia
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
434-297-5504
Facility:
Name:
Inova Schar Cancer Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
571-472-1180
Facility:
Name:
VCU Massey Cancer Center
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
804-628-3836
Facility:
Name:
Virginia Mason Medical Center
Address:
City:
Seattle
Zip:
98101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
206-624-1144
Facility:
Name:
ThedaCare Regional Cancer Center
Address:
City:
Appleton
Zip:
54911
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
920-364-3600
Start date:
February 27, 2024
Completion date:
January 2027
Lead sponsor:
Agency:
Cardiff Oncology
Agency class:
Industry
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Source:
Cardiff Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06106308
