Neratinib
Information
- Drug Name
- Neratinib
- Description
- Entry(CIViC)
- 21
CIViC
Annotation
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT03065387 | Active, not recruiting | Phase 1 | 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 | October 31, 2017 | October 1, 2025 |
| NCT03812393 | Active, not recruiting | Phase 2 | Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast | June 21, 2019 | December 15, 2024 |
| NCT04388384 | Active, not recruiting | Real-life Pan-HER-blockade With Neratinib | July 2, 2020 | January 2025 | |
| NCT03377387 | Active, not recruiting | Phase 1/Phase 2 | Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer | December 13, 2017 | December 2024 |
| NCT02932280 | Active, not recruiting | Phase 1/Phase 2 | Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment | October 2016 | October 2024 |
| NCT03101748 | Active, not recruiting | Phase 1/Phase 2 | Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer | January 29, 2018 | January 1, 2026 |
| NCT00550212 | Completed | Phase 1 | Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects | March 2008 | April 2008 |
| NCT00706030 | Completed | Phase 1/Phase 2 | Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer | April 29, 2008 | June 7, 2018 |
| NCT00708903 | Completed | Phase 1 | Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization) | May 2008 | July 2008 |
| NCT00741260 | Completed | Phase 1/Phase 2 | Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer | December 9, 2008 | June 2018 |
| NCT00757809 | Completed | Phase 1 | Study Evaluating The Tolerability Of Multiple Doses Of HKI-272 | October 2008 | October 2008 |
| NCT00768469 | Completed | Phase 1 | Study Evaluating Safety And Tolerability, Solid Tumor | October 2008 | January 2011 |
| NCT00777101 | Completed | Phase 2 | Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer | February 4, 2009 | June 3, 2018 |
| NCT00814060 | Completed | Phase 1 | Study Evaluating TwoTablet Formulations of Neratinib (HKI-272) | January 2009 | March 2009 |
| NCT00838539 | Completed | Phase 1 | Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors | April 2009 | December 2013 |
| NCT00860223 | Completed | Phase 1 | Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin | April 2009 | April 2009 |
| NCT00146172 | Completed | Phase 1 | Study Evaluating HKI-272 in Tumors | November 2003 | January 2007 |
| NCT00878709 | Completed | Phase 3 | Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer | July 9, 2009 | October 4, 2019 |
| NCT00915018 | Completed | Phase 2 | Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer | August 21, 2009 | June 28, 2018 |
| NCT00958724 | Completed | Phase 1 | Study Evaluating Neratinib In Combination With Vinorelbine In Subjects With Advanced Or Metastatic Solid Tumors | July 2009 | April 2010 |
| NCT01008150 | Completed | Phase 2 | Phase II Randomized Trial Evaluating Neoadjuvant Therapy With Neratinib and/or Trastuzumab Followed by Postoperative Trastuzumab in Women With Locally Advanced HER2-positive Breast Cancer | October 2010 | November 25, 2016 |
| NCT01111825 | Completed | Phase 1/Phase 2 | Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer | April 2010 | July 2016 |
| NCT01128842 | Completed | Phase 1 | A Study Of Neratinib (HKI-272) And Capecitabine In Japanese With Solid Tumor | April 2010 | March 2011 |
| NCT01142063 | Completed | A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects | June 2010 | September 2010 | |
| NCT01423123 | Completed | Phase 1 | Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer | May 2011 | March 2014 |
| NCT01670877 | Completed | Phase 2 | Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer | December 11, 2012 | March 11, 2021 |
| NCT01808573 | Completed | Phase 3 | A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting | March 29, 2013 | December 9, 2019 |
| NCT01827267 | Completed | Phase 2 | Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer | July 1, 2013 | October 6, 2017 |
| NCT02236000 | Completed | Phase 1/Phase 2 | A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer | August 2014 | August 2021 |
| NCT02334501 | Completed | Phase 1 | Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects | August 2014 | October 2014 |
| NCT02400476 | Completed | Phase 2 | An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide | February 2015 | April 22, 2021 |
| NCT02673398 | Completed | Phase 2 | Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer | December 2, 2016 | September 22, 2022 |
| NCT00864487 | Completed | Phase 1 | Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib | April 2009 | May 2009 |
| NCT00300781 | Completed | Phase 2 | Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer | August 4, 2006 | January 30, 2018 |
| NCT00366600 | Completed | Phase 1 | Study Evaluating HKI-272 Administered to Healthy Subjects | July 2006 | December 2006 |
| NCT00380328 | Completed | Phase 1 | HKI-272 Ketoconazole Drug Interaction Study | October 2006 | November 2006 |
| NCT00397046 | Completed | Phase 1 | A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors | November 2006 | March 2009 |
| NCT00498745 | Completed | Phase 1 | Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects | July 2007 | September 2007 |
| NCT03094052 | Completed | Phase 2 | Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib | October 9, 2018 | October 31, 2022 |
| NCT04366713 | Completed | Phase 2 | A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib | June 30, 2020 | December 28, 2021 |
| NCT01956253 | No longer available | Single Subject Neratinib in Bladder Cancer (NRR) | July 2013 | June 2014 | |
| NCT05154396 | Not yet recruiting | Phase 2 | Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer | January 1, 2022 | December 31, 2024 |
| NCT05491057 | Not yet recruiting | Treatment Patterns of Neratinib in HER2+ EBC in China | September 30, 2022 | June 30, 2026 | |
| NCT02977780 | Recruiting | Phase 2 | INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) | February 9, 2017 | December 31, 2025 |
| NCT01042379 | Recruiting | Phase 2 | I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | March 1, 2010 | December 2031 |
| NCT05388149 | Recruiting | Phase 2 | Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease | December 6, 2022 | July 2025 |
| NCT05615818 | Recruiting | Phase 3 | Personalized Medicine for Advanced Biliary Cancer Patients | May 29, 2024 | June 2028 |
| NCT05919108 | Recruiting | Phase 2 | Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers | September 30, 2024 | April 30, 2031 |
| NCT06109467 | Recruiting | Phase 2 | Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer | January 12, 2024 | April 2028 |
| NCT04374305 | Recruiting | Phase 2 | Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2) | June 20, 2020 | December 2030 |
| NCT05933395 | Recruiting | Phase 2 | Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor | October 10, 2023 | October 2031 |
| NCT04886531 | Recruiting | Phase 2 | Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers | July 21, 2022 | May 2024 |
| NCT05243641 | Recruiting | Phase 1/Phase 2 | Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test | August 18, 2022 | December 31, 2028 |
| NCT05252988 | Recruiting | Phase 2 | Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib | August 31, 2022 | January 2030 |
| NCT03919292 | Recruiting | Phase 1/Phase 2 | Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca | May 1, 2019 | December 31, 2025 |
| NCT03878524 | Terminated | Phase 1 | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | April 1, 2020 | December 10, 2020 |
| NCT02593708 | Terminated | Phase 1 | Phase1 of Neratinib+Trastuzumab, Pertuzumab, Paclitaxel in Patients With Advanced Solid Tumors/HER2+ | November 3, 2015 | July 31, 2017 |
| NCT03289039 | Terminated | Phase 2 | Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer | October 25, 2017 | July 20, 2021 |
| NCT01953926 | Terminated | Phase 2 | Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations | September 30, 2013 | January 2, 2023 |
| NCT03182634 | Unknown status | Phase 2 | The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial | December 15, 2016 | November 2023 |
| NCT03457896 | Unknown status | Phase 2 | Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status | May 18, 2018 | September 30, 2022 |
| NCT04781374 | Withdrawn | Phase 2 | Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer | May 21, 2021 | September 24, 2021 |
| NCT00932464 | Withdrawn | Phase 1 | Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib | August 2012 | August 2012 |
| NCT01960023 | Withdrawn | Phase 1/Phase 2 | Safety and Efficacy Study of Neratinib and Cetuximab to Treat Patients With Quadruple Wild-Type Metastatic Colorectal Cancer | October 2013 | July 13, 2016 |
| NCT04856475 | Withdrawn | Phase 2 | Evaluation of Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer | November 24, 2021 | November 24, 2021 |
| NCT04901299 | Withdrawn | Phase 2 | Fulvestrant + Neratinib In Breast Cancer | July 2023 | July 1, 2025 |
- Target (Drug list of Screening Committee of Anticancer Drugs)
- EGFR/Her2
- Synonym (Drug list of Screening Committee of Anticancer Drugs)
- PF-05208767
- Synonym (Drug list of Screening Committee of Anticancer Drugs)
- HKI-272
- Synonym (Drug list of Screening Committee of Anticancer Drugs)
- PB272