NL-OMON54680招募中2 期
A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients with BRAFV600-mutant Non-small Cell Lung Cancer - PfizerC4221005, Array 818-202, PHAROS
Array Biopharma Inc. (a wholly owned subsidiary of Pfizer Inc.)0 个研究点目标入组 25 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
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
- •Patients must meet all of the following criteria to be eligible for enrollment
- •in the study:
- •1. Able to provide written informed consent. Adult patients under guardianship
- •may participate with the consent of their legally authorized guardian if
- •permitted by local regulations.
- •2. Age >= 18 years at the time of informed consent.
- •3. Histologically confirmed diagnosis of NSCLC that is currently Stage IV (M1a,
- •M1b, M1c- AJCC 8th edition).
- •4. Presence of a BRAFV600E mutation in tumor tissue or blood (e.g., ctDNA
- •genetic testing) as determined by a local laboratory assay. Other Class 1
- •BRAFv600 mutations (e.g., K or D) will be permitted with prior discussion with
- •the Sponsor.
- •5. The Investigator must obtain prior to enrollment that the patient has
- •adequate tumor tissue for submission to a central laboratory for confirmation
- •of BRAFV600 mutation status.
- •6. Patients who are either treatment-naïve (e.g., no prior systemic therapy for
- •advanced/metastatic disease), OR who have received 1) first-line platinum-based
- •chemotherapy OR 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given
- •alone or in combination with platinum-based chemotherapy, or in combination
- •with immunotherapy (e.g., ipilimumab) with or without given alone or in
- •combination with platinum-based chemotherapy.
- •7. Presence of measurable disease based on RECIST v1.1.
- •8. ECOG performance status of 0 or 1.
- •9. Adequate bone marrow function characterized by the following at screening:
- •a. ANC >= 1.5 × 109/L;
- •b. Platelets >= 100 × 109/L;
- •c. Hemoglobin >= 8.5 g/dL (with or without blood transfusions).
- •10. Adequate hepatic and renal function characterized by the following at
- •a. Total bilirubin <= 1.5 × ULN
- •b. ALT and AST <= 2.5 × ULN, or <= 5 × ULN in presence of liver metastases;
- •c. Serum creatinine <= 1.5 × ULN; or calculated creatinine clearance
- •>= 50 mL/min by Cockcroft-Gault formula; or estimated glomerular filtration rate
- •> 50 mL/min/1.73m2.
- •11. Able to swallow, retain and absorb oral medications.
- •12. Willingness and ability to comply with scheduled visits, treatment plan,
- •laboratory tests and other study procedures.
- •13. Female patients of childbearing potential, must have a negative serum β-HCG
- •test result.
- •14. Female patients of childbearing potential must agree to use methods of
- •contraception that are highly effective or acceptable and to not donate ova
- •from Screening until 30 days after the last dose of study treatment.
- •15. Male patients must agree to use methods of contraception that are highly
- •effective or acceptable, and to not donate sperm from Screening until 90 days
- •after the last dose of study drug.
排除标准
- •Patients meeting any of the following criteria are ineligible for enrollment in
- •1. Patients who have documentation of any of the following: EGFR mutation, ALK
- •fusion oncogene or ROS1 rearrangement.
- •2. Patients who have received more than 1 prior line of systemic therapy in the
- •advanced/metastatic setting. Prior therapies can be reviewed with the Array
- •Medical Monitor.
- •3. Previous treatment with any BRAF inhibitor (e.g., dabrafenib, vemurafenib,
- •XL281/BMS-908662, etc.), or any MEK inhibitor (e.g., trametinib, cobimetinib,
- •selumetinib, RDEA119, etc.) prior to screening and enrollment.
- •4. Receipt of anticancer medications or investigational drugs within the
- •following intervals before the first administration of study treatment:
- •a. <= 14 days for chemotherapy, targeted small-molecule therapy, radiation
- •therapy, immunotherapy, or antineoplastic biologic therapy (e.g., erlotinib,
- •crizotinib, bevacizumab, etc.).
- •b. <= 14 days or 5 half-lives (minimum of 14 days) for investigational agents or
- •devices. For investigational agents with long half-lives (e.g., > 5 days),
- •enrollment before the fifth half-life requires medical monitor approval.
- •c. Palliative radiation therapy must be complete 7 days prior to the first dose
- •study treatment.
- •5. Patients who have had major surgery (e.g., inpatient procedure with regional
- •or general anesthesia) <= 6 weeks prior to start of study treatment.
- •6. Patient has not recovered to <= Grade 1 from toxic effects of prior therapy
- •and/or complications from prior surgical intervention before starting study
- •7. Current use of a prohibited medication (including herbal medications,
- •supplements or foods) or use of a prohibited medication <= 1 week prior to
- •the start of study treatment.
- •8. Impairment of gastrointestinal function or disease which may significantly
- •alter the absorption of oral study treatment (e.g., uncontrolled nausea,
- •vomiting or diarrhea, malabsorption syndrome, small bowel resection).
- •9. Impaired cardiovascular function or clinically significant cardiovascular
- •diseases, including any of the following:
- •a. 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;
- •b. Congestive heart failure requiring treatment (New York Heart Association
- •Grade >= 2);
- •c. LVEF < 50% as determined by MUGA or ECHO;
- •d. Uncontrolled hypertension defined as persistent systolic blood pressure
- •>= 150 mmHg or diastolic blood pressure >= 100 mmHg despite optimal therapy;
- •e. History or presence of clinically significant cardiac arrhythmias (including
- •uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular
- •tachycardia);
- •f. Triplicate average baseline QTcF interval >= 480 ms or a history of prolonged
- •10. History of thromboembolic or cerebrovascular events <= 12 weeks prior to the
- •first dose of study treatment. Examples include transient ischemic attacks,
- •cerebrovascular accidents, hemodynamically significant (i.e. massive or
- •sub-massive) deep vein thrombosis or pulmonary emboli.
- •11. History or current evidence of RVO or current risk factors for RVO (e.g.,
- •uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or
- •hypercoagulability syndromes
研究者
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