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临床试验/EUCTR2014-002460-33-IT
EUCTR2014-002460-33-IT进行中（未招募）不适用

ANTI MEK THERAPY WITH REFAMETINIB TO PREVENT RESISTANCE TO EGFR-TARGETED TREATMENT IN METASTATIC COLORECTAL CANCERS - ARES

FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA - IRCCS0 个研究点开始时间: 2014年7月10日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
发起方
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1. Patients must have pathologically confirmed metastatic colorectal cancer, which has recurred or progressed following oxaliplatin and irinotecan-based chemotherapy regimens administered for the treatment of metastatic disease, except if the patient was not a candidate for either agent or refused treatment with oxaliplatin or irinotecan. Prior antiangiogenic treatment with bevacizumab or regorafenib or other antiangiogenic agents is allowed but not mandatory.
  • •MANDATORY PRIOR ANTI-EGFR THERAPY
  • •ARES 0Indifferent
  • •ARES 2Mandatory
  • •2. The patient tumor molecular profile results must be known prior to study entry.
  • •MANDATORY MOLECULAR PROFILE
  • •ARES 0 ‘quintuple wild-type’, or KRAS codon 61 or NRAS codon 12,13 or 61 or BRAF V600E mutated
  • •ARES 1 ‘quintuple wild-type’and NO amplification of MET, HER2 and RAS
  • •ARES 2 ‘quintuple wild-type’, EGFR S492R WT, NO amplification of HER2 and RAS. Knowledge of the status of MET GCN is required but not mandatory.
  • •3. Patients must be willing to undergo pre-and post-treatment tumor biopsies if disease amenable to biopsy. However, failure to retrieve pathological sample on biopsy does not exclude patient from the trial.
  • •4. Patients must have completed any major surgery chemotherapy, radiation therapy, or biologic therapy greater than or equal to 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin C). Patients must be greater than or equal to 2 weeks since any prior administration of a study drug in an exploratory IND/Phase 0 study. Patients must have recovered to eligibility levels from any prior surgery, toxicity, or adverse events.
  • •5. Age greater than or equal to 18 years.
  • •6. Life expectancy of greater than 3 months.
  • •7. ECOG performance status less than 2.
  • •8. Patients must have normal organ and marrow function as defined below:
  • •Absolute neutrophil count >1.500/uL;
  • •Platelets > 100.000/Ul
  • •Haemoglobin > 8,5 g/dL
  • •Prothrombin time-international normalized ratio (PT-INR) =2.3, or PT =6 seconds above control.
  • •Patients who are therapeutically anti-coagulated with an agent such as warfarin or heparin are allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre-dose, as defined by the local standard of care.
  • •9. Total bilirubin less than or equal to 1.5 times institutional UNL.
  • •10. AST/ALT less than or equal to 3.0 times institutional UNL; less than or equal to 5.0 times institutional UNL if liver metastases.
  • •11. Creatinine less than 1.5 times UNL; or measured creatinine greater than or equal to 60 mL/minute for patients with clearance creatinine levels greater than or equal to 1.5 times UNL
  • •12. Albumin > 2.8 g/dL
  • •13. Amylase and lipase < 1.5 x ULN
  • •14. Women of child-bearing potential must have a negative pregnancy test prior to entry.
  • •15. Adequate contraception patient and partner (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 weeks after dosing with study medication ceases.
  • •16. Patients must be able to swallow whole tablets and capsules.
  • •17. Ability to understand and the willingness to sign a written informed consent document.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 83
  • •F.1.3 Elderly (>=65 years) yes

排除标准

  • •1. Previous treatment with a MEK inhibitor.
  • •2. Prior treatment with an anti-EGFR antibody or TKI agent (for ARES 1 and ARES 1 only).
  • •3. Patients receiving any other investigational agents.
  • •4. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study.
  • •5. Participation in another clinical trial or treatment with any investigational product within 4 weeks prior to inclusion in this study.
  • •6. Patients with history of hypersensitivity to, either IP or IP classes or excipients or monoclonal antibodies.
  • •7. Acute steroid therapy or taper for any purpose (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before start of screening and thereafter).
  • •8. Current evidence of retinal disease, history of central serous retinopathy (CSR) and or retinal vein occlusion (RVO), or visible retinal pathology as assessed by ophthalmology that is considered a risk factor for RVO or CSR.
  • •9. Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren’s syndrome), congenital abnormality (e.g. Fuchs’ dystrophy).
  • •10. Symptomatic or untreated leptomeningeal disease or brain metastases.
  • •11. Not adequate hematologic, renal and hepatic function including renal failure requiring hemo- or peritoneal dialysis.
  • •12. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
  • •13. Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
  • •14. History of cardiac disease: instable angina (angina symptoms at rest, new-onset angina i.e. within the last 3 months) or myocardial infarction (MI) within the past 6 months prior to start of screening.
  • •15. Cardiac arrhythmias requiring anti-arrhythmic therapy or CHF (Chronic Heart Failure of NYHA grade two or higher.)
  • •16. Uncontrolled hypertension already on optimal medication.
  • •17. Ongoing infection > Grade 2 according to NCI-CTCAE version 4.03.
  • •18. Known human immunodeficiency virus (HIV) infection.
  • •19. History of interstitial lung disease (ILD).
  • •20. Clinically significant GI bleeding (CTCAE 4.03 grade 3 or higher) within 30 days prior to start of screening.
  • •21. Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months prior to start of screening.
  • •22. History of organ allograft, cornea transplantation will be allowed.
  • •23. Non-healing wound, ulcer, or bone fracture.
  • •24. Patients with seizure disorder requiring medication.
  • •25. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
  • •26. Any condition that was unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
  • •27. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
  • •28. History of severe infusion reactions to monoclonal antibodies.
  • •29. Pregnant and lactating women.
  • •30. Any cancer curatively treated < 3 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Staging: Ta, Tis and T1).
  • •31. Use of strong inhibitors of CYP3A4 and strong inducers of CYP3A4 should be stopped 2 weeks before sta

研究者

发起方
FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA - IRCCS

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