Open Actively Recruiting

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


Brief 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.

Primary Purpose
Study Type
Phase 2


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

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

Join this Trial

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Study Stats
Protocol No.
Colorectal Cancer
Ruth Gonzalez
  • TRIO-US - Bakersfield
  • TRIO-US - Ft. Wayne IN
  • TRIO-US - Jonesboro AR
  • TRIO-US - Redondo Beach
  • TRIO-US - Whittier
  • TRIO-US - Wichita KS
  • UCLA Alhambra
  • UCLA Burbank
  • UCLA Encino
  • UCLA Irvine
  • UCLA Laguna Hills
  • UCLA Pasadena
  • UCLA Porter Ranch
  • UCLA San Luis Obispo
  • UCLA Santa Barbara
  • UCLA Santa Monica
  • UCLA Torrance
  • UCLA Valencia
  • UCLA Ventura
  • UCLA Westlake Village
  • UCLA Westwood
For Providers
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