EUCTR2018-000271-32-BE进行中（未招募）1 期
Phase II, open-label, single arm, multicenter study of encorafenib, binimetinib plus cetuximab in subjects with previously untreated BRAF V600E -mutant Metastatic Colorectal Cancer - ANCHOR CRC Study
Pierre Fabre Médicament0 个研究点目标入组 90 人开始时间: 2018年8月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
入选标准
- •1. Provide a signed and dated informed consent form.
- •2. Male or female = 18 years of age at time of informed consent.
- •3. Histologically or cytologically confirmed CRC that is metastatic and unresectable at time of study entry (i.e. not suitable for complete surgical resection at screening).
- •4. Presence of BRAFV600E mutation in tumor tissue previously determined by a local assay at any time prior to screening.
- •a. Only PCR and NGS-based local assays results will be acceptable.
- •b. If at any time there is lack of confirmation of the BRAFV600E mutation in a total of 6 subjects (= 6% of the total targeted 90 treated subjects) or discordance between the local assay and the central laboratory in 3 subjects (= 3% of the total targeted 90 treated subjects), all subsequent subjects will be required to have BRAFV600E determined by the central lab. prior to study treatment assignment.
- •c. Central testing cannot be repeated to resolve discordances with a local result once the central lab delivers a definitive result (positive or negative).
- •d. If the result from the central lab is indeterminate or the sample is deemed inadequate for testing, additional samples may be submitted (archival material only).
- •e. If more than 1 discordant result from any local lab lead to subject enrollment, subsequent results from this local laboratory will not be accepted for further subject enrollment.
- •5. Eligible to receive cetuximab per locally approved label with regards to tumor RAS status
- •e.g.: In agreement with EU label, evidence of wild type RAS (KRAS and NRAS) status in EU countries
- •6. Able to provide a sufficient amount of representative tumor specimen (primary or metastatic, archival or newly obtained) for testing of BRAF and RAS mutation status(FFPE tumor tissue block or a minimum of 10 slides, optimally up to 15 slides)
- •7. Evidence of measurable disease, as per RECIST 1.1.
- •Note: Lesions in areas of prior radiotherapy or other loco-regional therapies are considered measurable only if progression has been documented in the region following therapy.
- •8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- •9. Adequate bone marrow function at screening and baseline:
- •i. Absolute neutrophil count (ANC) = 1.5 x 1 000 000 000 /L.
- •ii. Platelets = 100 x 1 000 000 000/L
- •iii. Hemoglobin = 9.0 g/dL.
- •Blood transfusions are allowed provided that the subject has not received more than 2 units of red blood cells in the 4 weeks prior to achieve the minimum required hemoglobin level.
- •10. Adequate renal function at screening and baseline:
- •i. Serum creatinine = 1.5x upper limit of normal (ULN).
- •ii. Calculated creatinine clearance (CrCl)= 50 mL/min by Cockroft-Gault formula.
- •11. Adequate electrolytes at screening and baseline, defined as serum potassium and magnesium levels within institutional normal limits.
- •Replacement treatment to achieve adequate electrolytes will be allowed
- •12. Adequate hepatic function at screening and baseline:
- •i. Serum total bilirubin = 1.5 x ULN and < 2 mg/dL. Note: Tota
排除标准
- •1. Prior systemic therapy for metastatic disease.
- •Note: previous adjuvant/neoadjuvant therapy is allowed provided that 1) the interval from the end of chemotherapy to relapse is >6 months OR
- •2) in the case of neoadjuvant therapy, complete surgical resection was achieved and the interval from the end of chemotherapy to relapse is >12 months. Prior locoregional radiotherapy is allowed.
- •2. Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti- EGFR treatment.
- •3. Symptomatic brain metastasis.
- •Note: subjects previously treated or untreated for these conditions who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases must be stable for = 4 weeks with imaging
- •4. Leptomeningeal disease.
- •5. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity syndrome or hypercoagulability syndrome.
- •6. Use of any herbal medications/supplements or any medications or foods that are moderate or strong inhibitors or inducers of CYP3A4/5 = 1 week prior to the start of treatment.
- •Note: However, subjects who either discontinue moderate or strong inhibitors or inducers of CYP3A4/5 or switch to another medication at least 7 days prior to starting study treatment are eligible.
- •7. Known history of acute or chronic pancreatitis within 6 months prior to the start of the treatment.
- •8. History of chronic inflammatory bowel disease or Crohn’s disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) = 12 months prior to first dose.
- •9. Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- •i. History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) = 6 months prior to start of study treatment.
- •ii. Symptomatic congestive heart failure (Grade 2 or higher), history or current evidence of clinically significant arrhythmia and/or conduction abnormality = 6 months prior to start of study treatment, except atrial fibrillation and paroxysmal supraventricular tachycardia.
- •10. Uncontrolled hypertension defined as persistent elevation of systolic blood pressure = 150 mmHg or diastolic blood pressure = 100 mmHg despite optimal therapy.
- •11. Impaired hepatic function, defined as Child-Pugh class B or C.
- •12. No more applicable from protocol V6
- •13. Impaired gastrointestinal function or disease which may significantly alter the absorption of encorafenib or binimetinib or recent changes in bowel function suggesting current or impending bowel obstruction.
- •14. Previous or concurrent malignancy within 5 years of study entry or other noninvasive or indolent malignancy without Sponsor approval except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix.
- •15. History of thromboembolic or cerebrovascular events = 6 months prior to starting study treatment including transient is
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