Study on Onvansertib with Chemotherapy and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adults with KRAS or NRAS Mutation

Sponsor: Cardiff Oncology

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06106308

This clinical trial is testing the effectiveness and safety of a new drug, Onvansertib, combined with standard chemotherapy and Bevacizumab, for treating adults with metastatic colorectal cancer that has specific genetic mutations (KRAS or NRAS).

Patient Parameters

Program Overview

The aim of this study is to find the best dose of Onvansertib that works well and is safe when used with chemotherapy drugs (FOLFIRI or FOLFOX) and Bevacizumab. This treatment is for adults with metastatic colorectal cancer that has a KRAS or NRAS mutation and who have not received any previous treatment for their cancer in this advanced stage.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic colorectal cancer confirmed by lab tests.
  • Have a documented KRAS or NRAS mutation.
  • Have not received any previous treatment for metastatic cancer.
  • Be willing to provide a tissue sample or undergo a biopsy.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Women of childbearing potential must use contraception or take measures to avoid pregnancy.
  • Have recent imaging scans to document all cancer sites.
  • Have acceptable organ function as determined by medical tests.

Exclusion Criteria

  • Have both KRAS or NRAS and BRAF-V600 mutations or high microsatellite instability.
  • Have previously been treated with a VEGF inhibitor like Bevacizumab.
  • Have received oxaliplatin treatment within the last 12 months.
  • Have a known deficiency in dihydropyrimidine dehydrogenase (DPD).
  • Have received any cancer treatment within 28 days before starting the study drug.
  • Have untreated or symptomatic brain cancer spread.
  • Have gastrointestinal disorders that affect the absorption of oral medications.
  • Be unable or unwilling to swallow the study drug.
  • Have uncontrolled illnesses.
  • Have known allergies to certain chemotherapy drugs.
  • Have abnormal bilirubin processing or known Gilbert's syndrome.
  • Be using certain strong medications that affect liver enzymes.
  • Have a prolonged QT interval on an ECG (QTc greater than 470 milliseconds).

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