Clinical trial · Interventional
Folfiri/aflIbercept in Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status
seconD-line Folfiri/aflIbercept in proSpecTIvely Stratified, Anti-EGFR resistaNt, Metastatic coloreCTal Cancer patIents With RAS Validated Wild typE Status
NCT04252456CI-TRIAL-00043180DISTINCTIVEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will a be a biologically enriched, prospectively stratified phase II trial in RAS wild type metastatic colorectal cancer patients progressing after first-line treatment with oxaliplatin, fluoropyrimidines and an anti-EGFR monoclonal antibody. All patients will receive aflibercept in combination with FOLFIRI according to the Italian label.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aflibercept, 5fluorouracil, Folinic Acid andIrinotecan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- standard chemotherapy for advanced colorectal cancer
- description
- All patients will receive aflibercept in combination with FOLFIRI according to the Italian label.
- interventionNames
- Procedure: Aflibercept, 5fluorouracil, Folinic Acid andIrinotecan
Primary outcomes (1)
- measure
- Overall survival (OS) according to VEGFR2 levels, evaluating the difference in terms of median OS among patients with high VEGFR2 activity and patients with low VEGFR2 activity
- timeFrame
- From date of randomization until the date of death from any cause, whichever came first, assessed up to 3 years
- description
- Overall survival time is defined as the time from inclusion to the date of death. If subject has not died, survival will be censored on the last date the subject was known to be alive (last date of follow-up)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * • Histological confirmation of colorectal cancer * Confirmed RAS wild type patient treated with an oxaliplatin-anti EGFR treatment in 1st line * At least one lesion measurable with CT or MRI scan * Radiologically documented progression while on or after discontinuation of treatment with FOLFOX in combination with an anti-EGFR monoclonal antibody (either cetuximab or panitumumab) * Radiologically documented progressing disease after FOLFOX in combination with an anti-EGFR monoclonal antibody (either cetuximab or panitumumab) * Life expectancy plus 3 months * Netrophils count ³ 1.5 x 109/L * Platelets count ³ 100 x 109/L * Hemoglobin ³ 9 g/dL * Creatinine £ 1.5 mg/dL, Proteinuria \<2+ (dipstick urinalysis) or ≤1g/24hour.Bilirubin £ 1.5 x ULN * AST and ALT £ 2.5 x ULN (\< 5 ULN in case of liver metastases) * Informed written consent * ECOG Performance Status \< 2 * Age plus18 yrs * Regular follow-up feasible. * For female patients of childbearing potential, negative serum pregnancy test within 1 week (7 days) prior of starting study treatment, * Female patients must commit to using reliable and appropriate methods of contraception until at least six months after the end of study treatment Exclusion Criteria: * • Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy), * Treatment with any other investigational medicinal product within 28 days prior to First Study treatment. * Other serious and uncontrolled non-malignant disease, * History or evidence upon physical examination of CNS metastasis unless adequately treated * Gilbert's syndrome * Intolerance to atropine sulfate or loperamide * Known dihydropyrimidine dehydrogenase deficiency * Treatment with CYP3A4 inducers unless discontinued \> 7 days prior to First Study treatment. * Any of the following in 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis. * Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for \>5 years, * Major surgery or traumatic injury within the last 28 days or until the surgical wound is fully healed whichever came later * Pregnant or breastfeeding women, * Patients with known allergy to any excipient to study drugs, * Bowel obstruction. * Uncontrolled infections * Known drugs or alcohol abuse * History of severe cardiovascular disease within 6 months prior to First Study treatment Uncontrollable hypertension, when treated with three or more drugs.
References
Publications (0)
Data not yet available
No reference posted for this study.