NL-OMON55423已完成不适用
An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered with Encorafenib and Binimetinib in Patients with BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors - Array 818-103
Array BioPharma Inc. (a wholly ownd subsidairy of Pfizer Inc.)0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed written informed consent;
- •2. Male or female patient, age >= 18 years;
- •3. Histologically confirmed diagnosis of locally advanced, unresectable or
- •metastatic cutaneous melanoma or unknown primary melanoma American Joint
- •Committee on Cancer (AJCC) Stage IIIB, IIIC or IV; or other BRAF V600-mutant
- •advanced solid tumors;
- •4. Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to
- •enrollment, as determined using a local test;
- •5. Evidence of measurable or non-measurable lesions as detected by radiological
- •or photographic methods according to guidelines based onResponse Evaluation
- •Criteria in Solid Tumors (RECIST) v. 1.1;
- •6. Patient with unresectable locally advanced or metastatic melanoma who has
- •progressed on standard therapy and for whom no additional standard therapies
- •are available.
- •Note: Prior therapy with a BRAF inhibitor (e.g., vemurafenib, dabrafenib,
- •encorafenib and XL281/BMS-908662) and/or a MEK inhibitor (e.g., trametinib,
- •binimetinib, selumetinib, cobimetinib and refametinib) is permitted except in
- •the regimen immediately prior to study entry. Progression during prior BRAF/MEK
- •inhibitor treatment is not required;
- •7. Patient with other (non-melanoma) BRAF V600E and/or V600K -mutant advanced
- •solid tumors who has progressed on standard therapy or for whom there are no
- •available standard therapies
- •Note: Prior therapy with a BRAF inhibitor and/or a MEK inhibitor is permitted
- •except in the regimen immediately prior to study entry. Progression during
- •prior BRAF/MEK inhibitor treatment is not required; if it occurred, the
- •patient*s circumstances (e.g., >= 1 year since prior BRAF and/or MEK inhibitor,
- •equivocal progression, refractory to available therapies) must be discussed
- •with the Sponsor prior to enrollment;
- •8. ECOG PS of 0 or 1;
- •9. Adequate bone marrow, organ function and laboratory parameters:
- •a. Absolute neutrophil count (ANC) >= 1.5 x 109/L,
- •b. Hemoglobin (Hgb) >= 9 g/dL without transfusions,
- •c. Platelets (PLT) >= 100 x 109/L without transfusions,
- •d. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) <= 2.5
- •× upper limit of normal (ULN); patient with liver metastases <= 5 ×ULN,
- •e. Total bilirubin <= 2 × ULN,
- •f. Creatinine <= 1.5 mg/dL, or calculated creatinine clearance (determined as
- •per Cockcroft-Gault) >= 50 mL/min;
- •10. Able to take oral medications;
- •11. Patient is deemed by the Investigator to have the initiative and means to
- •be compliant with the protocol (treatment and follow-up);
- •12. Negative serum beta-human chorionic gonadotropin (β-HCG) test (female
- •patient of childbearing potential only) performed within 72 hours prior to
- •first dose and consent to ongoing urine pregnancy testing during the course of
- •13. Male patients and female patients of childbearing potential must agree to
- •use an acceptable method of contraception as defined in the study protocol;
- •ARM 1 ONLY:
- •1. Non-smoker who has not used nicotine containing products for at least 3
- •months prior to the first dose.
排除标准
- •1. Symptomatic brain metastasis. Patients previously treated or untreated for
- •these conditions who are asymptomatic in the absence of corticosteroid and
- •anti-epileptic therapy are allowed. ;
- •2. History of reaction to any of the study medications in the arm the patient
- •is enrolled in this trial;
- •3. Use, within 2 weeks prior to the start of encorafenib/binimetinib treatment
- •on Day 1 and through DDI phase (Day 28), of any herbal medications/supplements
- •or any medications or foods that are moderate or strong inhibitors or inducers
- •of CYP3A4/5;
- •4. Consumption of grapefruit, pomegranates, star fruits, Seville oranges or
- •products containing the juice of each starting from Day -14 and through the DDI
- •phase (Day 28), due to potential CYP3A4 interaction with the study drugs.
- •Orange juice is allowed;
- •5. Symptomatic or untreated leptomeningeal disease;
- •6. 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 or hypercoagulability syndromes);
- •7. Clinically significant cardiac disease including any of the following:
- •a. Congestive heart failure requiring treatment (New York Heart Association
- •Grade >= 2)
- •b. Left ventricular ejection fraction (LVEF) < 50% as determined by MUGA or
- •c. Uncontrolled hypertension defined as persistent systolic blood pressure >=
- •150 mmHg or diastolic blood pressure >= 100 mmHg despite current therapy
- •d. History or presence of clinically significant ventricular arrhythmiasor
- •atrial fibrillation
- •e. Clinically significant resting bradycardia
- •f. Unstable angina pectoris <= 3 months prior to start of study drug
- •g. Acute myocardial infarction <= 3 months prior to start of study drug
- •h. QT interval corrected for heart rate using the Fridericia formula (QTcF)
- •> 480 msec at screening;
- •8. Impaired hepatic function as defined by Child-Pugh class B or C;
- •9. Impaired gastrointestinal function or disease which may significantly alter
- •the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea,
- •vomiting, diarrhea, malabsorption syndrome, small bowel resection);
- •10. Known hyper-coagulability risks other than malignancy (e.g., Factor V
- •Leiden syndrome);
- •11. Thromboembolic event (e.g. including transient ischemic attacks,
- •cerebrovascular accidents, deep vein thrombosis or pulmonary emboli) except
- •catheter-related venous thrombosis <= 12 weeks prior to starting study
- •treatment. Note: Patients with catheter-related thromboembolic events are
- •12. Any of the following:
- •a. Nitrosourea or mitomycin-C within 6 weeks prior to start of study drug
- •b. Other chemotherapy, radiation therapy that included > 30% of the bone
- •marrow reserve, or biological therapy (e.g., antibodies) within 4 weeks prior
- •to start of study drug
- •c. Continuous or intermittent small-molecule therapeutics or investigational
- •agents within 5 half-lives of the agent (or within 4 weeks prior to start of
- •study drug, when half-life is unknown)
- •d. Residual Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 side
- •effects of any such therapy (residual Grade 2 alopecia is permitted);
- 另有 2 项未显示
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