Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06106308
Other study ID # CRDF-004
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 27, 2024
Est. completion date January 2027

Study information

Verified date May 2024
Source Cardiff Oncology
Contact Nancy Sherman
Phone 858-952-7570
Email patients@cardiffoncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date January 2027
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Onvansertib
Oral capsule
FOLFIRI
FOLFIRI (irinotecan + fluorouracil [5-FU] + leucovorin) as intravenous (IV) infusion
Bevacizumab
IV Infusion
FOLFOX
FOLFOX (leucovorin + fluorouracil [5-FU] + oxaliplatin) as intravenous (IV) infusion

Locations

Country Name City State
United States Pacific Cancer Medical Center Anaheim California
United States Comprehensive Blood and Cancer Center - Bakersfield Bakersfield California
United States University of Virginia Charlottesville Virginia
United States Trihealth Kenwood Cincinnati Ohio
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States West Cancer Clinic Germantown Tennessee
United States Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion Grand Rapids Michigan
United States Memorial Cancer Institute Hollywood Florida
United States Kaiser Permanente Honolulu Hawaii
United States MD Anderson Cancer Center Houston Texas
United States Mayo Clinic - Florida Jacksonville Florida
United States St. Bernards Medical Center Jonesboro Arkansas
United States CCCN Las Vegas Nevada
United States Norris Comprehensive Cancer Center Los Angeles California
United States Manhattan Hematology Oncology (MHO) Research Foundation, Inc. New York New York
United States Mayo Clinic - Arizona Phoenix Arizona
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Washington University School of Medicine Center for Advanced Medicine Saint Louis Missouri
United States Utah Cancer Specialists Salt Lake City Utah
United States Virginia Mason Medical Center Seattle Washington
United States Torrance Memorial Physician Network - Cancer Care and Infusion Center Torrance California
United States The University of Kansas Cancer Center - Westwood Westwood Kansas
United States PIH Health Whittier California
United States Cancer Center of Kansas Wichita Kansas

Sponsors (2)

Lead Sponsor Collaborator
Cardiff Oncology Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) ORR defined as the proportion of participants who achieved a best overall Response (BOR) of CR or PR per RECIST Version 1.1 from randomization until disease progression, or death due to any cause, as determined by blinded independent central review. Up to approximately 1 year
Secondary Progression Free Survival (PFS) PFS defined as the time from the date of randomization to the earliest documented disease progression per RECIST version 1.1, or death due to any cause, as determined by blinded independent central review. Up to approximately 1 year
Secondary Duration of Response (DOR) DOR defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause, as determined by blinded independent central review. Up to approximately 1 year
Secondary Number of Participants with an Adverse Event (AE) Type, incidence, causality and severity of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Clinically significant changes from baseline in vital signs, laboratory parameters, electrocardiograms (ECGs), weight, and Eastern Cooperative Oncology Group (ECOG) performance status will be recorded as AEs. Up to approximately 1 year
Secondary Disease Control Rate (DCR) DCR defined as CR plus PR plus stable disease (SD), as determined by independent central review. Up to approximately 1 year
Secondary Overall Survival (OS) OS defined as the time from drug administration to death due to any cause. Up to approximately 1 year
Secondary Overall Response (OR) Defined as CR or PR, PFS, DCR, DOR, and OS associated with a reduction in circulating tumor DNA (ctDNA) mutation allele frequency (MAF). Up to approximately 1 year
Secondary Maximum Concentration (Cmax) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Secondary Area Under the Plasma Concentration Curve (AUC) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Secondary Trough Concentration (Ctrough) of Onvansertib and metabolites in combination w/FOLFIRI and bevacizumab or FOLFOX and bevacizumab Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Secondary Efficacy: Exposure Response Evaluation of Onvansertib Up to approximately 1 year
Secondary Safety: Exposure Response Evaluation of Onvansertib Up to approximately 1 year
See also
  Status Clinical Trial Phase
Completed NCT01228734 - A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients Phase 3
Completed NCT05178745 - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Completed NCT01591421 - P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer. Phase 1/Phase 2
Withdrawn NCT05412706 - Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy Phase 2
Withdrawn NCT04430985 - FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer Phase 2
Withdrawn NCT03182894 - Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT05725200 - Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer Phase 2
Terminated NCT03176264 - PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer Phase 1
Completed NCT04866290 - HepaSphereâ„¢ Microspheres Prospective Registry
Not yet recruiting NCT06425133 - Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers Phase 2
Not yet recruiting NCT05531045 - 18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Completed NCT02906059 - Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer Phase 1
Active, not recruiting NCT02575378 - Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer Phase 4
Withdrawn NCT02535988 - Abscopal Effect for Metastatic Colorectal Cancer Phase 2
Recruiting NCT02848807 - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life N/A
Active, not recruiting NCT02077868 - Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment Phase 3
Completed NCT02414009 - Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients Phase 2
Active, not recruiting NCT01949194 - Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers Phase 2
Withdrawn NCT01915472 - A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer Phase 2