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Evaluation of the personalised treatment of colorectal cancer by regorafenib based on therapeutic and pharmacological monitoring
EU CTIS ID: 2024-517241-13-00
What this study is testing
The primary objective of the trial is to determine whether "optimal exposure" to regorafenib based on plasma concentration of the drug and its metabolites can improve overall survival in mCRC patients.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients ≥ 18 years-old at time of Informed Consent Form (ICF) signature
- Women of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy
- Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior randomization
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Patients affiliated to the Social Security System
- Signed and dated informed consent
You likely can't join if
- Prior treatment with regorafenib, and with any prior antiangiogenic inhibitor except bevacizumab
- Breastfeeding
- Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite optimal medical management)
- Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), within 6 months before the start of study medication
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
- Myocardial infarction less than 6 months before the start of study medication
See the full eligibility criteria
Who can join
- Male or female patients ≥ 18 years-old at time of Informed Consent Form (ICF) signature
- Women of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy
- Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior randomization
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Patients affiliated to the Social Security System
- Signed and dated informed consent
- Patients must have a histologically proven metastatic colorectal cancer
- Patients who have previously been treated with standard therapy including a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF (bevacizumab or aflibercept) and an anti-EGFR (cetuximab or panitumumab) for patients who had a RAS wild-type tumor.
- In mCRC with MSI-H, the patient must have received immunotherapy. For mCRC with BRAF mutation, the patient should have received a BRAF inhibitor if eligible.
- ECOG PS = 0 or 1
- Imaging target greater than one cm must be visible on CT
- Patients must have adequate bone marrow, renal, and hepatic function, as evidenced by the pre-therapeutic check-up performed within 7 days before regorafenib initiation
- INR/PTT ≤1.5 x ULN
- Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. For patient treated with VKA close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care
What rules you out
- Prior treatment with regorafenib, and with any prior antiangiogenic inhibitor except bevacizumab
- Breastfeeding
- Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite optimal medical management)
- Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), within 6 months before the start of study medication
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
- Myocardial infarction less than 6 months before the start of study medication
- Any hemorrhage or bleeding event ≥ Grade 3, NCI-CTCAE v 5.0 within 4 weeks prior to the start of study medication
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days before start of study medication
- Non-healing wound, ulcer or bone fracture
- Unresolved toxicity higher than Grade 1, NCI-CTCAE v 5.0, attributed to any prior therapy/procedure excluding alopecia, anemia, hypothyroidism and oxaliplatin induced neuropathy
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Hypersensitivity to the active substance or to any of the excipients
- Adults legally protected (judicial protection, guardianship or supervision), person deprived of their liberty
- Systemic cancer therapy with unfinished washout (in general 3 weeks except for example for capecitabin which has a 1 week washout)
- Concomitant treatment with a cytochrome P450 3A4 (CYP3A4) inducer or inhibitor or UGT1A9 inhibitor
- Patients unable to swallow oral medication
- Digestive obstruction, chronic inflammatory bowel disease or any malabsorption condition
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria])
- Ongoing uncontrolled infection (viral, bacterial or fungal)
- Known history of human immunodeficiency virus (HIV) infection, active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.