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Onvansertib in Combination With FOLFIRI/Bevacizumab or FOLFOX/Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer

NCT06106308Phase 2

Key facts

Status: Active, not recruiting
Start: Feb 2024
Primary completion: Nov 2026
Countries: 1
Sponsor: Cardiff Oncology
Modality: Small Molecules

Drugs: onvansertib
Conditions: metastatic colorectal cancer (mCRC)

Overview

Phase 2, randomised, open-label trial of onvansertib in metastatic colorectal cancer (mCRC) (6 arms), sponsored by Cardiff Oncology. Primary endpoint: Objective Response Rate. Started Feb 2024; status: active, not recruiting.

Design

6 arms

Study design: RandomizedOpen-label

Onvansertib 20mg + FOLFIRI/Bev
Onvansertib 20 mg on Days 1-5 and 15-19 + FOLFIRI/Bev on Day 1 and 15 of each 28-day cycle.
Onvansertib 30mg + FOLFIRI/Bev
Onvansertib 30 mg on Days 1-5 and 15-19 + FOLFIRI/Bev on Day 1 and 15 of each 28-day cycle.
FOLFIRI/Bev (SOC)
FOLFIRI/Bev on Day 1 and 15 of each 28-day cycle.
Onvansertib 20mg + FOLFOX/Bev
Onvansertib 20 mg on Days 1-5 and 15-19 + FOLFOX/Bev on Day 1 and 15 of each 28-day cycle.
Onvansertib 30mg + FOLFOX/Bev
Onvansertib 30 mg on Days 1-5 and 15-19 + FOLFOX/Bev on Day 1 and 15 of each 28-day cycle.
FOLFOX/Bev (SOC)
FOLFOX/Bev on Day 1 and 15 of each 28-day cycle.

Who it enrols

Patients with histologically confirmed metastatic colorectal cancer with a documented KRAS or NRAS mutation, no previous systemic therapy in the metastatic setting, ECOG PS 0-1, and acceptable organ function. Excludes patients with concomitant BRAF-V600 mutation or MSI-H/dMMR, prior VEGF inhibitor treatment, or recent oxaliplatin treatment.

Endpoints

Primary

Objective Response RateUp to approximately 1 year

Secondary

Progression Free SurvivalUp to approximately 1 year
Duration of ResponseUp to approximately 1 year
Number of Participants with an Adverse EventUp to approximately 1 year
Disease Control RateUp to approximately 1 year
Overall SurvivalUp to approximately 1 year
Overall ResponseUp to approximately 1 year
Maximum Concentration of Onvansertib and metabolitesDay 5 of Cycle 3
Area Under the Plasma Concentration Curve of Onvansertib and metabolitesDay 5 of Cycle 3

Results

Not all primary endpoints met

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