Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer

Inclusion Criteria19

• Willing and able to give written informed consent (for each part of the study) for participation in the clinical performance study.
• 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.
• Patient is eligible for another line of tumour directed therapy on failure of the SoC.
• 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:
• Haemoglobin at least 10.0 g/dL.
• Neutrophils at least 1.5 x109/L (without current use of colony-stimulating factors).
• Platelets at least 100 x109/L.
• AST/ALT no higher than 2xULN when patient does not have metastatic disease in the liver, or no higher than 5xULN when patient has metastatic disease in the liver.
• Bilirubin no higher than 1.5xULN when patient does not have metastatic disease in the liver, or no higher than 2xULN when patient has metastatic disease in the liver.
• Albumin no lower than 30 g/L.
• INR within normal level.
• Creatinine no higher than 1.5xULN.
• For Part A: the treating physician should follow contraceptive requirements described in the SmPC of respective treatment.
• For Part B: women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the patient) or must agree to use a highly effective method of contraception with a failure rate of <1 % to prevent pregnancy from at least 2 weeks prior to the screening visit of Part B to 4 weeks after the last administration of IMP in Part B. In addition, any male partner of a female participant must, unless he has undergone vasectomy, agree to use a condom from the screening visit of Part B until 4 weeks after the last administration of IMP in Part B.
• The following are considered highly effective methods of contraception:
• combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),
• progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable),
• intrauterine device \[IUD\]or intrauterine hormone-releasing system \[IUS\]) WOCBP must refrain from donating eggs from the first IMP administration until 3 months after the last IMP administration. WOCBP with an exclusive male partner who has undergone vasectomy may chose not to use contraceptives.
• Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone \[FSH\] >25 IU/L is confirmatory). Male participants must be willing to use condom or be vasectomised or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the first administration of IMP until 4 weeks after the last administration of IMP. Any female partner of a non-vasectomised male participant who is of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above) from at least 2 weeks prior to the first administration of IMP to 4 weeks after the last administration of IMP.