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Regorafenib as second-line treatment of patients with RAS-mutant advanced colorectal cancer: a multicentre, phase 2 study - STREAM-2
EU CTIS ID: 2024-519669-23-00
What this study is testing
To assess the anti-tumor efficacy of regorafenib as second line treatment in mCRC RAS-mutant patients, eligible to a second line treatment, and with good prognostic features, measured as progression-free survival rate at 6 months
- 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
- Written informed consent to study procedures and to correlative studies.
- Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL.
- Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN
- Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula)
- Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range.
- Known dihydropyrimidine dehydrogenase (DPYD) activity is mandatory. Additional analysis of polymorphisms uridine diphosphate-glycosyltransferase 1 (UGT1A1) enzyme is recommended but not mandatory
You likely can't join if
- Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment
- Complete deficiency of activity of dihydropyrimidine dehydrogenase (DPYD).
- Any contraindication to regorafenib.
- Not received immunotherapy if dMMR or MSI-H
- Major surgical intervention within 4 weeks prior to enrollment.
See the full eligibility criteria
- Written informed consent to study procedures and to correlative studies.
- Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL.
- Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN
- Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula)
- Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range.
- Known dihydropyrimidine dehydrogenase (DPYD) activity is mandatory. Additional analysis of polymorphisms uridine diphosphate-glycosyltransferase 1 (UGT1A1) enzyme is recommended but not mandatory
- Either sex aged ≥ 18
- Histologically proven of colorectal adenocarcinoma
- Diagnosis of metastatic disease.
- RAS mutant at initial diagnosis assessed at local centers according with a validated method defined by EMA and known MMR/MSI status
- Achieved a PFS in first line > 6 months with chemotherapy in combination to antiangiogenic treatment OR with one metastatic site at study entry
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry
- Imaging-documented measurable disease, according to RECIST 1.1 criteria.
- Estimated life expectancy of more than 12 weeks
- Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment
- Complete deficiency of activity of dihydropyrimidine dehydrogenase (DPYD).
- Any contraindication to regorafenib.
- Not received immunotherapy if dMMR or MSI-H
- Major surgical intervention within 4 weeks prior to enrollment.
- Pregnancy and breast-feeding.
- Any brain metastasis.
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.
- History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form.
- Participation in any interventional drug or medical device study within 30 days prior to treatment start.
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, 65+ years, 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.