A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4/6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial

This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.

开始日期2024-11-08

申办/合作机构

National Cancer Institute

NCT05919108 / Not yet recruiting临床2期IIT

Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.

开始日期2024-04-30

申办/合作机构

The Vanderbilt-Ingram Cancer Center

[+2]

NCT06374888 / Not yet recruiting临床2期

A Single-arm, Open, Multicenter Phase II Clinical Study of Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases

To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis.

开始日期2024-04-30

申办/合作机构

甫康（上海）健康科技有限责任公司

100 项与马来酸奈拉替尼相关的临床结果

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100 项与马来酸奈拉替尼相关的转化医学

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100 项与马来酸奈拉替尼相关的专利（医药）

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530

项与马来酸奈拉替尼相关的文献（医药）

2024-03-01·European Journal of Cancer

Revolutionizing anti-HER2 therapies for extrahepatic cholangiocarcinoma and gallbladder cancer: Current advancements and future perspectives

Review

作者: Pedregal, Manuel ; Prato, Javier ; Moreno, Victor ; Lamarca, Angela ; Klümpen, Heinz-Josef ; Ten Haaft, Britte Hea

Biliary tract cancers (BTCs) encompass a heterogeneous group of rare tumors, including intrahepatic cholangiocarcinoma (iCCA), extrahepatic cholangiocarcinoma (eCCA), gallbladder cancer (GBC) and ampullary cancer (AC). The present first-line palliative treatment regimen comprises gemcitabine and cisplatin in combination with immunotherapy based on two randomized controlled studies. Despite the thorough investigation of these palliative treatments, long-term survival remains low. Moving beyond conventional chemotherapies and immunotherapies, the realm of precision medicine has demonstrated remarkable efficacy in malignancies such as breast and gastric cancers, characterized by notable HER2 overexpression rates. In the context of biliary tract cancer, significant HER2 alterations are observed, particularly within eCCA and GBC, heightening the interest in precision medicine. Various anti-HER2 therapies, including trastuzumab, pertuzumab, trastuzumab-deruxtecan, zanidatamab and neratinib, have undergone investigation. The objective of this review is to summarize the current evidence and outline future directions of targeted HER2 treatment therapy in patients with biliary tract tumors, specially extrahepatic cholangiocarcinoma and gallbladder cancer.

2024-02-01·Anti-Cancer Drugs

Autophagy as a therapeutic mechanism to kill drug-resistant cancer cells

Article

作者: Roberts, Jane L ; Poklepovic, Andrew ; Dent, Paul ; Booth, Laurence

Herein we discuss multiple pre-clinical projects developed by our group that have been translated into patients at Massey Cancer Center. Our work has used multi-kinase inhibitors, for example, sorafenib, regorafenib and neratinib, and combined with additional agents, for example, histone deacetylase inhibitors, the thymidylate synthase inhibitor pemetrexed, and PDE5 inhibitors. In broad-brush terms, our experience has been that these drug combinations enhance signaling by ATM-AMPK-ULK-1 and decrease signaling from growth factor receptors and RAS proteins, thereby lowering the activities of the intracellular signaling kinase ERK1/2, AKT, mTOR and p70S6K. This collectively results in reduced protein synthesis and the induction of an endoplasmic reticulum stress response alongside autophagosome formation and autophagic flux. The rupture of autolysosomes, releasing proteases such as cathepsin B into the cytosol results in the cleavage and activation of the toxic BH3 domain protein BID which cooperates with BAX, BAK and BIM to cause mitochondrial dysfunction, leading to the release of cytochrome c and AIF, which then execute the tumor cell. For each of our two-drug combinations, we then performed additional laboratory-based studies to define the development of evolutionary resistance mechanisms, with the long-term concept of performing new three-drug clinical trials to prolong therapeutic efficacy and disease control.

2024-02-01·Gynecologic Oncology

Targeting HER2-mutant metastatic cervical cancer with neratinib: Final results from the phase 2 SUMMIT basket trial

Article

作者: Goldman, Jonathan ; Eli, Lisa D ; Melisko, Michelle E ; Panni, Stefano ; Ravichandran, Vignesh ; Frazier, Aimee L ; D'Souza, Anishka ; Oaknin, Ana ; de Miguel, Maria ; Friedman, Claire F ; DiPrimeo, Daniel ; Gambardella, Valentina ; Tinker, Anna V ; Spanggaard, Iben ; Loi, Sherene ; ElNaggar, Adam C ; Solit, David B ; Shapiro, Geoffrey I ; Bello Roufai, Diana

OBJECTIVE:

HER2 mutations are associated with poor prognosis and are detected in 3-6% of cervical cancers. Neratinib, an irreversible pan-HER tyrosine kinase inhibitor, had activity in several HER2-mutant cancer types in the phase 2 SUMMIT basket study. We present updated and final results from the cervical cancer cohort of SUMMIT.

METHODS:

Eligible patients had HER2-mutant, metastatic or recurrent cervical cancer progressing after platinum-based treatment for advanced/recurrent disease. Patients received neratinib 240 mg/day; loperamide was mandatory during cycle 1. Confirmed objective response rate (ORR) was the primary endpoint. Duration of response (DoR), clinical benefit rate (CBR), progression-free survival (PFS), and safety were secondary endpoints.

RESULTS:

Twenty-two patients were enrolled; 18 (81.8%) had endocervical adenocarcinoma; median two prior systemic chemotherapy regimens (range 1-4). The most common HER2 variant was S310F/Y mutation (n = 13; 59.1%). Four patients had confirmed partial responses (ORR 18.2%; 95% CI 5.2-40.3); 6 had stable disease ≥16 weeks (CBR 45.5%; 95% CI 24.4-67.8). Median DoR was 7.6 months (95% CI 5.6-12.3). Median PFS was 5.1 months (95% CI 1.7-7.2). All-grade diarrhea (90.9%), nausea (54.5%), and constipation (54.5%) were the most common adverse events. Five patients (22.7%) reported grade 3 diarrhea. There were no grade 4 adverse events, no diarrhea-related treatment discontinuations, and two grade 5 adverse events, unrelated to neratinib: dyspnea (n = 1) and embolism (n = 1).

CONCLUSIONS:

Neratinib resulted in durable responses and disease control in patients with HER2-mutant metastatic/recurrent cervical cancer in SUMMIT. These findings support next-generation sequencing and tailored therapy for select patients with advanced cervical cancer. All responses occurred in patients with endocervical adenocarcinoma. Further assessment of neratinib in this setting is warranted.

TRIAL REGISTRATION NUMBER:

NCT01953926 (ClinicalTrials.gov), 2013-002872-42 (EudraCT).

140

项与马来酸奈拉替尼相关的新闻（医药）

2024-04-18

·BioSpace

Puma Biotechnology to Host Conference Call to Discuss First Quarter 2024 Financial Results

LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 2, 2024, following the release of its first quarter 2024 financial results. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at . A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. Further information about Puma Biotechnology may be found at .

上市批准引进/卖出财报

2024-04-17

·美通社

亚虹医药发布2023年年报：核心产品APL-1702全球III期临床成功 APL-1706国内NDA获受理专科商业化团队"造血"初具成效

上海 2024年4月17日 /美通社/ -- 4月17日，亚虹医药发布的2023年年报显示，公司专科化战略取得显著成果：临床开发、早期研究及商业化多管齐下，齐头并进。截至目前，公司主要产品管线拥有13个产品、16个在研项目。报告期末货币资金与交易性金融资产约23.33亿元，资金储备充足，为公司的稳健发展提供保障。多个产品临床开发取得里程碑进展积极推进新药上市亚虹医药用于非手术治疗宫颈高级别鳞状上皮内病变（High-Grade Squamous Intraepithelial Lesion，HSIL）的光动力药械组合产品APL-1702的国际多中心Ⅲ期临床试验于2023年9月达到主要研究终点。研究结果显示，在主要疗效终点上，APL-1702组的应答率较安慰剂对照组的应答率提高了89.4%（41.1% vs. 21.7%，p = 0.0001），同时APL-1702提高了高危HPV16和/或HPV18的清除率，较对照组提高103.9%（31.4% vs. 15.4%），且不良事件发生率较低。上述临床结果入选2024年欧洲生殖器官感染和肿瘤研究组织大会（EUROGIN）和2024年美国妇科肿瘤学会年会（SGO），并均以大会口头报告的形式发布。 APL-1702是全球首个经国际Ⅲ期临床验证、疗效确切的HSIL非手术治疗产品。该产品的出现有望重新定义宫颈癌前病变的治疗目标，使临床治疗从此前的关注切除手术的一次性治疗效果，转变到聚焦疾病的长期管理，并且尤其注意平衡治疗的获益和风险，在逆转疾病的前提下尽可能避免和推迟损伤性的外科手术治疗。目前，公司正在积极准备向国家药品监督管理局（NMPA）递交APL-1702的上市申请，预计将于2024年第二季度获得上市申请的受理。就APL-1702的未来开发，公司将积极推进开展本地化生产；适时启动第二代产品的开发；拟于2024年第三季度向欧洲药品管理局（EMA）提交上市申请前的沟通申请；期望于2024年与美国FDA沟通交流在北美市场的注册临床方案设计，并适时递交在北美开展注册III期临床研究的申请；积极寻求APL-1702合作开发海外市场的机会。亚虹医药用于膀胱癌诊断和管理的药物APL-1706的多中心Ⅲ期临床试验于2023年8月达到主要研究终点。研究结果显示，在中国患者中，APL-1706联合蓝光膀胱镜（BLC，blue light cystoscopy）在膀胱癌检测方面优于白光膀胱镜 (WLC，white light cystoscopy)，尤其是原位癌（CIS，carcinoma in situ）的检出，并且其耐受性良好。该产品的Ⅲ期临床结果以及真实世界研究结果入选多个国际学术会议，包括2023年国际泌尿外科学会年会（SIU）、2024年美国临床肿瘤协会泌尿生殖肿瘤分会年会（ASCO-GU）等。 APL-1706是目前全球唯一获批的辅助膀胱癌诊断和管理的显影剂类药物，联合使用APL-1706和蓝光膀胱镜作为非肌层浸润性膀胱癌（NMIBC）管理的方法已被纳入全球专家共识指南及中国泌尿外科和男科疾病诊断治疗指南。APL-1706尚未在中国上市。目前该产品的上市申请已于2023年11月获得NMPA受理。公司正在积极推进其上市审评审批工作，并期望于2025年6月底前获得上市批准。此外，虽然2024年初APL-1202与化疗灌注联用治疗非肌层浸润性膀胱癌的一项关键性临床试验未能达到主要疗效终点，但是APL-1202与替雷利珠单抗联合新辅助治疗肌层浸润性膀胱癌的II期临床试验已于2023年9月完成II期临床试验期中分析，并取得积极结果，结果显示，APL-1202和替雷利珠单抗联用治疗组病理完全缓解率（pCR）相较于替雷利珠单抗单药治疗组的大幅提升（39% vs 21%），同时联合治疗组显示出可接受的安全性特征。该结果已入选2024年美国临床肿瘤学会泌尿生殖系统肿瘤研讨会（ASCO GU），并以快速口头报告摘要的形式发布。上述期中分析结果提示，APL-1202可以大幅提高替雷利珠单抗的组织学缓解率。基于此，公司拟在中国晚期膀胱化疗治疗失败的人群中开展APL-1202联合免疫检查点抑制剂的临床研究，并尽快与国家药品监督管理局药品审评中心（CDE）沟通递交临床试验申请；拟在美国进行开展二代产品APL-1501联合免疫检查点抑制剂治疗BCG无反应、伴有或不伴有乳头状肿瘤的原位癌（CIS）的非肌层浸润性膀胱癌的临床研究，并拟于2024年与FDA沟通交流注册性临床开发计划。同时，公司还在积极推动APL-1202及APL-1501的海外开发和合作机会，期望通过对外授权的方式降低海外开发成本并增加公司现金收入。围绕专注领域升级早研技术平台持续输出候选药物在临床开发取得积极进展的同时，公司早研平台也进行了升级调整，围绕专注领域形成三大支柱性平台，包括靶向免疫调节正常化（TIMN）技术平台、靶向和AI驱动的药物发现技术平台（Targeted & AI-driven Drug Discovery, TAIDD）、药械联用技术平台（Drug Device Combination, DDC）。同时，公司积极探索具有高度创新性的抗体药物偶联技术（ADC）、原位膀胱肿瘤模型技术（IOBC）等前沿技术，持续为公司输出候选药物。公司基于TAIDD平台开发了APL-2302（卵巢癌、乳腺癌等）、AT-014（泌尿系统肿瘤）、AT-017（乳腺癌等）和AT-018（卵巢癌、乳腺癌等），基于DDC平台开发了APLD-2304（NMIBC诊断和手术），基于ADC技术开发了AT-020（多种实体肿瘤）和AT-021（乳腺癌和其他实体瘤）等临床前产品。 2023年，公司研发投入金额约3.65亿元，同比增长49.49%；研发人员198人，同比增长12.50%。专科商业化团队初具规模自我造血能力提升同期，亚虹医药也在不断加强商业化团队战斗力，提升自我造血能力。报告期内，公司实现营业收入1375.33万元，比上年同期增加1372.72万元，收入主要来自产品销售收入及新增对外授权数据产生的许可费收入等。公司成立肿瘤药物事业部和女性健康事业部，做好专注领域产品的商业化。公司的肿瘤药物事业部通过引进用于强化辅助治疗早期乳腺癌的马来酸奈拉替尼片（商品名：欧优比）和晚期肾细胞癌治疗的培唑帕尼片（商品名：迪派特）两个产品，迅速组建了一支初具规模、功能完备的营销团队。迪派特、欧优比分别于2023年10月及2023年12月上市并开始销售，至2023年末即取得了928.92万元销售额的成绩。截至目前，肿瘤事业部已初步搭建完毕，期望在2024年实现迪派特、欧优比销售收入的快速增长，销售额过亿并实现整个事业部内部盈亏平衡，以打造公司在同行业中领先的商业化能力和运营效能。与此同时，随着公司用于治疗HSIL的产品APL-1702的国际Ⅲ期临床获得成功，公司快速成立了女性健康事业部，以专注于做好APL-1702在中国市场的营销和扩大在女性健康领域的管线，更好地满足女性健康患者的未满足临床需求。亚虹医药创始人、董事长、首席执行官潘柯博士表示：公司始终围绕泌尿生殖系统这一蓝海市场进行布局，尤其是针对早期膀胱癌和宫颈癌前病变这两个细分赛道，不断落实研发专科化战略，通过三大技术平台和多项特有技术，2023年输出了多个具有高度差异化的候选药物。尽管APL-1202与化疗联用的临床试验未达预期，但总体上看，多个产品在临床开发获得里程碑式进展，特别是APL-1702的III期临床成功，意味着在宫颈癌前病变的非手术治疗可望有重大的突破。同时，我们还打造了一支具备战斗力的专科化营销团队，加速实现自我造血功能。展望未来，我们将继续致力于服务专科化的产品管线和以诊疗一体化为特点的商业化建设，并积极推动产品的海外开发和合作机会，期望能够为社会和股东创造更多价值。前瞻性陈述的风险声明：上述内容包含涉及的公司未来计划、发展战略等的前瞻性陈述，不构成公司对投资者的实质承诺，请投资者注意投资风险。公司的前瞻性陈述主要基于公司对未来事件及趋势的当前预期及预测，公司认为此类未来事件及趋势可能会影响公司的业务、财务状况及经营业绩。

临床3期临床成功

2024-04-02

·PRNewswire

THE PANCREATIC CANCER ACTION NETWORK NAMES ANNA BERKENBLIT, MD, MMSc AS FIRST-EVER CHIEF SCIENTIFIC AND MEDICAL OFFICER

LOS ANGELES, April 2, 2024 /PRNewswire/ -- The Pancreatic Cancer Action Network (PanCAN), the leading nonprofit in the fight against pancreatic cancer, announces Anna Berkenblit, MD, MMSc, a clinical oncologist and drug developer, as its first-ever chief scientific and medical officer. In this role, Dr. Berkenblit will be responsible for the organization's overall scientific and clinical strategy, including PanCAN-sponsored studies, research grants, health data, business development, and patient services, to align with the organization's goal of improving outcomes for pancreatic cancer patients. Continue Reading Anna Berkenblit, MD, MMSc, joins the Pancreatic Cancer Action Network (PanCAN) as its first-ever Chief Scientific and Medical Officer "I'm thrilled to bring my expertise in patient care and clinical research to help accelerate progress for patients with pancreatic cancer so they can thrive," said Dr. Berkenblit. "And I'm really excited to join PanCAN to build on our scientific and medical initiatives to take PanCAN to the next phase of growth." This newly created role will oversee the current and future vision, strategy development, prioritization, and resource allocation of scientific and medical initiatives. Dr. Berkenblit will be part of the executive team reporting directly to PanCAN President and CEO Julie Fleshman, J.D., MBA. "We are honored to welcome Dr. Berkenblit to PanCAN as our first-ever chief scientific and medical officer. She will serve as a thought leader for us in the pancreatic cancer scientific and medical community working with our external advisors and stakeholders," said Fleshman. "We are excited to leverage her expertise as she helps us lay out a vision for PanCAN's role over the next decade to improve patient outcomes through research, better early detection strategies, and improved treatment options." Dr. Berkenblit brings over two decades of experience in clinical development of novel anticancer therapies in the life science industry. Most recently, she served as chief medical officer at ImmunoGen, where she led the development of ImmunoGen's novel, wholly owned product candidates, including Elahere™, which recently received full approval by FDA for platinum-resistant ovarian cancer. Prior to that, Dr. Berkenblit was senior vice president, clinical development at H3 Biomedicine, and vice president, head of clinical research at AVEO Oncology. She also held positions of increasing responsibility at Wyeth/Pfizer, becoming vice president, neratinib asset team leader in the Pfizer Oncology Business Unit. Over the course of her career, she has led the clinical development of oncology products spanning early testing to registration trials, which will be key as she continues leading PanCAN's commitment to innovation. "As a clinical trialist and medical oncologist, I am excited about the future of PanCAN and partnering with the most innovative people in the field to invest our resources as we continue to find new ways to detect, treat, and manage pancreatic cancer," said Dr. Berkenblit. Dr. Berkenblit earned an MD from Harvard Medical School, and an MMSc in the clinical investigator training program at Harvard/MIT Health Sciences & Technology. She completed her internship and residency at Brigham and Women's Hospital and went on to a hematology/oncology fellowship at Beth Israel Deaconess Medical Center (BIDMC). Prior to transitioning to industry, she led the Phase I oncology clinical trial program at BIDMC as part of the Dana-Farber/Harvard Cancer Center. To learn more about PanCAN and its mission to save lives, visit pancan.org or follow PanCAN on X, Instagram and Facebook. About the Pancreatic Cancer Action Network The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive. For 18 years in a row, PanCAN has earned a Four-Star Rating from Charity Navigator – the highest rating an organization can receive. This rating designates PanCAN as an official "Give with Confidence" charity, indicating strong financial health, ongoing accountability and transparency. Media Contact: Charaighn Sesock, PanCAN 559-972-4877 [email protected] SOURCE Pancreatic Cancer Action Network

高管变更临床1期

100 项与马来酸奈拉替尼相关的药物交易

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-	马来酸奈拉替尼	L01XE45	DB11828

研发状态

适应症	最高研发状态	国家/地区	公司
乳腺癌	批准上市	文莱更多	Puma Biotechnology, Inc. 更多
HER2阳性乳腺癌	批准上市	中国更多	Puma Biotechnology, Inc. 更多
晚期 HER2 阳性乳腺癌	无进展	保加利亚更多	Puma Biotechnology, Inc. 更多
早期乳腺癌	无进展	阿根廷更多	Puma Biotechnology, Inc. 更多
晚期乳腺癌	无进展	泰国更多	Puma Biotechnology, Inc. 更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01953926 (SUMMIT, Pubmed)	临床2期	子宫颈转移癌 HER2 mutations	22	Neratinib 240mg/day	淵鏇簾糧鏇製範壓衊窪(艱選夢餘獵鹽蓋簾遞壓) = 憲壓醖醖網壓獵觸觸築膚蓋窪遞觸積網願蓋醖 (遞鹽夢淵夢襯鏇選憲餘, 5.2 ~ 40.3) 更多	-	2024-01-10
NCT03094052 (CTgov)	临床2期	3型乳腺癌 \| HER2阳性乳腺癌 \| 腹泻	11	Loperamide+Trastuzumab+Neratinib+Diphenoxylate Hydrochloride/Atropine Sulfate	簾鹹壓鏇願鑰膚廠膚遞(網餘範衊鑰範簾鹹積製) = 憲壓積鹹繭壓鹹糧壓鬱夢襯願願鏇齋構積夢顧 (製範遞齋製願鏇鬱衊鑰, 鑰鑰醖鑰蓋遞憲鹹醖築 ~ 夢壓鹹蓋膚觸製網鏇鑰) 更多	-	2023-11-18
Literature 人工标引	N/A	药物引起的腹泻	11	Crofelemer+loperamide	蓋製簾鏇鏇願艱鹹壓願(鹽襯製網網鑰範範鹽鏇) = 鹽衊鹹壓選繭壓醖淵醖鑰繭鑰艱獵淵遞淵築醖 (糧觸獵淵窪餘願製鹽艱 )	积极	2023-07-04
Literature 人工标引	N/A	药物引起的腹泻	11	neratinib+loperamide	蓋製簾鏇鏇願艱鹹壓願(鹽襯製網網鑰範範鹽鏇) = 齋鬱願襯廠膚鑰製遞範鑰繭鑰艱獵淵遞淵築醖 (糧觸獵淵窪餘願製鹽艱 )	积极	2023-07-04
NCT04460430 (SOLTI-1718 NEREA Trial, SABCS2023)	临床2期	HR阳性/HER2阴性乳腺癌 HER2-negative \| PAM50 HER2-E	12	Neratinib + Exemestane	廠選憲醖膚襯觸遞築願(齋蓋製鑰鑰憲艱夢鹽製) = 鏇淵範簾膚膚製鏇獵範艱襯窪選壓鑰廠廠獵憲 (獵鏇選顧糧獵築餘簾窪, 0.2% ~ 38.5%) 更多	不佳	2023-06-01
NCT04460430 (SOLTI-1718 NEREA Trial, SABCS2023)	临床2期	HR阳性/HER2阴性乳腺癌 HER2-negative \| PAM50 HER2-E	12	Neratinib + Fulvestrant	廠憲艱淵製願願構壓鹽(繭糧壓餘憲鑰鏇鹽廠築) = 遞繭鏇憲簾遞網觸積構範衊夢鏇積壓齋蓋觸蓋 (膚製鏇淵醖艱鑰醖醖範 )	不佳	2023-06-01
SABCS2023	N/A	HR阳性/HER2阳性乳腺癌辅助 HER2-positive	62	Neratinib	鹹鹽餘簾繭淵構獵壓鬱(廠築製鏇簾襯艱鹽築簾) = 衊壓範醖網醖構願選鏇襯構願獵餘鹹壓衊蓋構 (齋鏇憲鹹齋製鹹淵憲鏇 ) 更多	-	2023-05-15
NCT03289039 (CTgov)	临床2期	HER2阳性转移性乳腺癌 \| 乳腺癌	21	Neratinib (Neratinib)	願鹹廠鏇蓋積遞夢顧獵(築窪顧窪構襯廠鏇鏇糧): Hazard Ratio (HR) = 1.06 (95% CI, 0.27 ~ 4.12), P-Value = 0.98 更多	-	2023-03-21
NCT03289039 (CTgov)	临床2期	HER2阳性转移性乳腺癌 \| 乳腺癌	21	Fulvestrant+Neratinib (Neratinib + Fulvestrant)		-	2023-03-21
NCT01953926 (SUMMIT, Pubmed \| Nat Commun)	临床2期	晚期胆管癌	25	Neratinib 240mg	範鹽襯襯膚製觸積鏇積(積廠窪襯壓築醖鬱構艱) = 範憲鹹衊淵憲鹹願窪願鬱顧鏇遞鑰製夢醖築範 (觸膚廠選積選壓網壓醖, 4.5 ~ 36.1)	-	2023-02-06
NCT02236000 (CTgov)	临床1/2期	HER2阳性乳腺癌	49	T-DM1+Neratinib	簾糧廠製鏇簾簾鑰壓積(淵淵遞積鏇製鹹製構鏇) = 夢齋鑰鹽鬱遞壓窪網簾醖獵膚構醖鹹餘製艱醖 (遞餘鹹製積鬱憲鬱餘鬱, 艱簾繭獵顧憲餘壓製窪 ~ 艱範齋繭繭壓鏇鬱衊鑰) 更多	-	2023-01-26
NCT01953926 (SUMMIT, NEWS) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Exon 18 Mutation	29	Neratinib	製遞製壓廠繭範繭蓋顧(壓築鏇糧選糧範壓鬱齋) = 願壓齋鑰鏇壓夢廠廠獵艱選簾簾顧襯鑰窪齋獵 (鹽簾鬱壓鹽衊鬱窪鬱鬱 ) 更多	积极	2022-10-27
NCT01953926 (SUMMIT, ESMO2022) 人工标引	临床2期	复发性结直肠癌 \| 转移性结直肠癌 HER2 mutation	22	neratinib 240 mg	觸艱淵醖淵壓獵製製選(淵夢顧齋觸鹹壓選獵構) = 夢齋鏇築鏇鹽糧構網鹽製觸積鑰網鏇糧積網窪 (壓衊齋壓簾製鬱鹽選糧, 1.7 ~ 7.2) 更多	积极	2022-09-10
NCT01953926 (SUMMIT, ESMO2022) 人工标引	临床2期	复发性结直肠癌 \| 转移性结直肠癌 HER2 mutation	22	Prior treatment with bevacizumab + neratinib 240 mg	觸艱淵醖淵壓獵製製選(淵夢顧齋觸鹹壓選獵構) = 鬱願襯繭繭築襯願鏇鹹製觸積鑰網鏇糧積網窪 (壓衊齋壓簾製鬱鹽選糧, 1.7 ~ 7.2) 更多	积极	2022-09-10