{"id":"hki-272","safety":{"commonSideEffects":[{"rate":"20-30%","effect":"Fatigue"},{"rate":"20-30%","effect":"Nausea"},{"rate":"10-20%","effect":"Diarrhea"},{"rate":"10-20%","effect":"Vomiting"},{"rate":"10-20%","effect":"Rash"}]},"_chembl":{"chemblId":"CHEMBL5665391","moleculeType":null,"molecularWeight":"543.03"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"By inhibiting the HER2 tyrosine kinase, HKI-272 prevents the activation of downstream signaling pathways that promote cell proliferation and survival, thereby exerting its anti-tumor effects.","oneSentence":"HKI-272 is a small molecule inhibitor of the human epidermal growth factor receptor 2 (HER2) tyrosine kinase.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T03:50:15.657Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic breast cancer, HER2 positive"},{"name":"Locally advanced or metastatic breast cancer, HER2 positive"}]},"trialDetails":[{"nctId":"NCT06126276","phase":"PHASE2","title":"Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-05-07","conditions":"Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm","enrollment":70},{"nctId":"NCT05564377","phase":"PHASE2","title":"Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-04-07","conditions":"Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8","enrollment":2900},{"nctId":"NCT05372614","phase":"PHASE1","title":"Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene","status":"SUSPENDED","sponsor":"National Cancer Institute (NCI)","startDate":"2022-10-05","conditions":"Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm","enrollment":33},{"nctId":"NCT03101748","phase":"PHASE1, PHASE2","title":"Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2018-02-19","conditions":"Breast Inflammatory Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma","enrollment":34},{"nctId":"NCT01494662","phase":"PHASE2","title":"HKI-272 for HER2-Positive Breast Cancer and Brain Metastases","status":"COMPLETED","sponsor":"Dana-Farber Cancer Institute","startDate":"2012-02","conditions":"Breast Cancer","enrollment":140},{"nctId":"NCT03065387","phase":"PHASE1","title":"Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2017-10-31","conditions":"Advanced Malignant Solid Neoplasm, EGFR Gene Amplification, EGFR Gene Mutation","enrollment":93},{"nctId":"NCT07019272","phase":"","title":"Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study","status":"NOT_YET_RECRUITING","sponsor":"Hebei Medical University Fourth Hospital","startDate":"2025-06-30","conditions":"HER2-positive Breast Cancer","enrollment":170},{"nctId":"NCT03878524","phase":"PHASE1","title":"Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial","status":"TERMINATED","sponsor":"OHSU Knight Cancer Institute","startDate":"2020-04-01","conditions":"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Anatomic Stage IV Breast Cancer AJCC v8, Anemia","enrollment":2},{"nctId":"NCT02673398","phase":"PHASE2","title":"Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer","status":"COMPLETED","sponsor":"City of Hope Medical Center","startDate":"2016-12-02","conditions":"HER2 Positive Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7","enrollment":25},{"nctId":"NCT00878709","phase":"PHASE3","title":"Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2009-07-09","conditions":"Breast Cancer","enrollment":2840},{"nctId":"NCT01128842","phase":"PHASE1","title":"A Study Of Neratinib (HKI-272) And Capecitabine In Japanese With Solid Tumor","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2010-04","conditions":"Advanced Malignant Solid Tumors","enrollment":7},{"nctId":"NCT00768469","phase":"PHASE1","title":"Study Evaluating Safety And Tolerability, Solid Tumor","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2008-10","conditions":"Advanced Malignant Solid Tumors","enrollment":10},{"nctId":"NCT01111825","phase":"PHASE1, PHASE2","title":"Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2010-04","conditions":"Breast Cancer","enrollment":99},{"nctId":"NCT00838539","phase":"PHASE1","title":"Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2009-04","conditions":"Neoplasms, Malignant Carcinoma","enrollment":63},{"nctId":"NCT00146172","phase":"PHASE1","title":"Study Evaluating HKI-272 in Tumors","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2003-11","conditions":"Breast Neoplasms","enrollment":73},{"nctId":"NCT00397046","phase":"PHASE1","title":"A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2006-11","conditions":"Tumors","enrollment":21},{"nctId":"NCT00741260","phase":"PHASE1, PHASE2","title":"Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2008-12-09","conditions":"Breast Cancer","enrollment":105},{"nctId":"NCT00915018","phase":"PHASE2","title":"Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2009-08-21","conditions":"Breast Cancer","enrollment":479},{"nctId":"NCT00300781","phase":"PHASE2","title":"Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2006-08-04","conditions":"Breast Neoplasms, Neoplasms","enrollment":136},{"nctId":"NCT00706030","phase":"PHASE1, PHASE2","title":"Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2008-04-29","conditions":"Breast Cancer, Advanced Malignant Solid Tumors","enrollment":92},{"nctId":"NCT00777101","phase":"PHASE2","title":"Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2009-02-04","conditions":"Advanced Breast Cancer, Breast Cancer","enrollment":233},{"nctId":"NCT00445458","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2007-09-11","conditions":"Advanced Breast Cancer, Advanced Malignant Solid Tumors, Breast Neoplasms","enrollment":110},{"nctId":"NCT00398567","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2007-04-04","conditions":"Advanced Breast Cancer","enrollment":45},{"nctId":"NCT01827267","phase":"PHASE2","title":"Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2013-07-01","conditions":"HER2-mutant Non-Small Cell Lung Cancer","enrollment":62},{"nctId":"NCT00958724","phase":"PHASE1","title":"Study Evaluating Neratinib In Combination With Vinorelbine In Subjects With Advanced Or Metastatic Solid Tumors","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2009-07","conditions":"Advanced Malignant Solid Tumors","enrollment":6},{"nctId":"NCT00266877","phase":"PHASE2","title":"Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2005-12","conditions":"Carcinoma, Non-Small-Cell Lung, Lung Neoplasms","enrollment":172},{"nctId":"NCT00366600","phase":"PHASE1","title":"Study Evaluating HKI-272 Administered to Healthy Subjects","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2006-07","conditions":"Healthy","enrollment":56},{"nctId":"NCT00498745","phase":"PHASE1","title":"Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2007-07","conditions":"Healthy","enrollment":36},{"nctId":"NCT00814060","phase":"PHASE1","title":"Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2009-01","conditions":"Healthy Subjects","enrollment":24},{"nctId":"NCT00708903","phase":"PHASE1","title":"Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2008-05","conditions":"Breast Cancer","enrollment":60},{"nctId":"NCT00550212","phase":"PHASE1","title":"Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2008-03","conditions":"Healthy","enrollment":6},{"nctId":"NCT00860223","phase":"PHASE1","title":"Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2009-04","conditions":"Healthy","enrollment":27},{"nctId":"NCT00932464","phase":"PHASE1","title":"Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib","status":"WITHDRAWN","sponsor":"Puma Biotechnology, Inc.","startDate":"2012-08","conditions":"Healthy","enrollment":""},{"nctId":"NCT01142063","phase":"","title":"A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2010-06","conditions":"Healthy","enrollment":28},{"nctId":"NCT00757809","phase":"PHASE1","title":"Study Evaluating The Tolerability Of Multiple Doses Of HKI-272","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2008-10","conditions":"Healthy Subjects","enrollment":50},{"nctId":"NCT00380328","phase":"PHASE1","title":"HKI-272 Ketoconazole Drug Interaction Study","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2006-10","conditions":"Healthy","enrollment":24},{"nctId":"NCT00781430","phase":"PHASE1","title":"Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2009-04","conditions":"Hepatic Insufficiency","enrollment":27},{"nctId":"NCT00864487","phase":"PHASE1","title":"Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib","status":"COMPLETED","sponsor":"Puma Biotechnology, Inc.","startDate":"2009-04","conditions":"Healthy Subjects","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":45,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["neratinib","Neratinib"],"phase":"phase_2","status":"active","brandName":"HKI-272","genericName":"HKI-272","companyName":"Puma Biotechnology, Inc.","companyId":"puma-biotechnology-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HKI-272 is a small molecule inhibitor of the human epidermal growth factor receptor 2 (HER2) tyrosine kinase. Used for Metastatic breast cancer, HER2 positive, Locally advanced or metastatic breast cancer, HER2 positive.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}