Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation

Conditions

• Colorectal Cancer
• Metastatic Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Onvansertib — DRUG
  Oral capsule
• FOLFIRI — DRUG
  FOLFIRI (irinotecan + fluorouracil \[5-FU\] + leucovorin) as intravenous (IV) infusion
• Bevacizumab — DRUG
  IV infusion

Study Details

The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil \[5-FU\], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.

Key Dates

Start date

Mar 17, 2023

Status verified

Jan 2025

Primary completion

Dec 9, 2024

Completion

Dec 9, 2024

Study Design

Enrollment

23 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Onvansertib 20 mg + Standard of Care (SOC)
  Participants will receive 20 mg of onvansertib on Days 1 to 5 and 15 to 19 of a 28-day treatment cycle and SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle.
• Experimental: Onvansertib 30 mg + Standard of Care (SOC)
  Participants will receive 30 mg of onvansertib on Days 1 to 5 and 15 to 19 of a 28-day treatment cycle and SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle.
• Active Comparator: Standard of Care (SOC)
  Participants will receive SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to approximately 1 year ]

Locations (27)

Find similar trials in Phoenix, AZ

Related Studies

• Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients
  Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee
• ColoCare Study - Colorectal Cancer Cohort
  Recruiting · University of Utah · Los Angeles, California
• Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers
  Recruiting · University of Missouri-Columbia · Columbia, Missouri
• A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
  PHASE1/PHASE2 · Recruiting · Merus B.V. · La Jolla, California