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West Cancer Center
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COLORECTAL: METASTATIC: 1st LINE: KRAS mutant: CRDF-004

A Phase 2, Randomized, Open-label 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 Patients With a KRAS or NRAS Mutation

Title
Cardiff CRDF-004 (Colon 1st Line)
Study Title

A Phase 2, Randomized, Open-label 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 Patients With a KRAS or NRAS Mutation

Site Link
NCT06106308
Malignancy
Colorectal, colon, rectum, rectal
Stage
Stage 4
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line
Investigational Agent
Onvansertib
Drug Class
Polo-like kinase 1 inhibitor
PI
Brad Somer, MD
Sponsor
Cardiff Oncology
Phase
Phase 2
Status
Open to Enrollment
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Metastatic CRC
  • Documented KRAS or NRAS mutation
  • No prior systemic therapy in metastatic setting
  • ECOG PS 0-1
  • No BRAF mutation, no MSI-h
  • No prior treatment with VEG-F inhibitor
  • No DPD dficiency
  • No untreated or symptomatic CNS mets
Objective
  • Primary
    • ORR
  • Secondary
    • PFS
    • DOR
    • AE
    • DCR
    • OS
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Adenocarcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
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