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

Conditions

• CRC
• KRAS/NRAS Mutation
• 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
• FOLFOX — DRUG
  FOLFOX (leucovorin + fluorouracil \[5-FU\] + oxaliplatin) as intravenous (IV) infusion

Study Details

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.

Key Dates

Start date

Feb 27, 2024

Status verified

Jan 2026

Primary completion

Nov 30, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

113 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 1 year ]

Locations (41)

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