FLUOROURACIL for Metastatic colorectal cancer

Inclusion criteria

• {"criterion_text":"- Willing and able to give written informed consent (for each part of the study) for participation in the clinical performance study.\n- Male or female patients, ≥18 years of age, with Eastern Cooperative Oncology Group (ECOG) performance status 0-1, who have metastatic lesions in the liver or peritoneum (or lymph nodes) that are radiologically assessable and can be biopsied, and who have recently failed 1st-line systemic therapy (2nd line for patients with three standard therapy lines) for unresectable metastatic disease and will shortly commence a new line of standard therapy.\n- Patient is eligible for another line of tumour directed therapy on failure of the SoC.\n- Patient has the following laboratory values, as measured in serum/plasma within 14 days prior to signing of informed consent for participation in Part A and B, respectively, indicative of adequate organ function: (see protocol for full laboratory values)."}

Exclusion criteria

• {"criterion_text":"- Life expectancy < 3 months.\n- Planned treatment or treatment with another investigational drug or investigational device within 3 months prior to the day of the tumour sampling procedure.\n- Patients who are pregnant, or currently breastfeeding.\n- Investigator considers the patient unlikely to comply with clinical performance study procedures, restrictions and requirements."}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with a successful biopsy yielding a µCAN report.","definition_or_measurement_approach":"No additional definition or measurement approach provided in the CTIS record."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients with a successful biopsy yielding a µCAN report within 56 days (8 weeks).","definition_or_measurement_approach":"Timeframe specified: within 56 days (8 weeks). No further measurement detail provided."}
• {"endpoint_text":"- Proportion of patients with a successful biopsy yielding a µCAN report with at least one drug therapy nomination.","definition_or_measurement_approach":"As stated: proportion of patients with a µCAN report that includes at least one drug therapy nomination. No further detail provided."}
• {"endpoint_text":"- Frequency, intensity and seriousness of adverse events (AEs) related to device or study procedures.","definition_or_measurement_approach":"As stated: safety will be assessed by reporting frequency, intensity and seriousness of AEs related to device or procedures. No further detail provided."}
• {"endpoint_text":"- Frequency and nature of device deficiencies (DD).","definition_or_measurement_approach":"As stated: capture frequency and nature of device deficiencies. No further detail provided."}
• {"endpoint_text":"- Device user experience questionnaire.","definition_or_measurement_approach":"As stated: user experience assessed by questionnaire. No further detail provided."}

Methods

• Site-based recruitment by the recruiting Investigator at participating study sites: 'All mCRC patients treated at the participating study site may be considered eligible for study participation based on the judgement of the recruiting Investigator.'

Norway

Earliest CTIS Part Ii Submission Date

31-03-2025

Latest Decision Or Authorization Date

29-04-2025

Processing Time Days

29

Number Of Sites

1

Number Of Participants

75

Primary sponsor

Full Name

Oncosyne AS

Organisation Type

Pharmaceutical company

Country Of Registered Address

Norway