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Clinical trials
catalyst calendar across sponsors →Studies where PBYI is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
36 interventional · 2 observational · 21 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)NCT07465757Percentage of Participants with Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)Non-randomized · Open-label · Treatment | Phase 2 | Not yet recruiting | Drug: Alisertib, Alisertib, Alisertib, Alisertib, Alisertib, Paclitaxel | Small Cell Lung Cancer ( SCLC ) | 50 | 2028-03-31 | in 590 d | 2026-03-12 |
| A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast CancerNCT06369285Objective Response Rate (ORR) Within Dose SubgroupRandomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: Alisertib, Endocrine therapy | Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer | 225 | 2027-12-30 | in 498 d | 2026-07-27 |
| A Study of Alisertib in Patients With Extensive Stage Small Cell Lung CancerNCT06095505Objective response rate (ORR) within biomarker-defined subgroupOpen-label · Treatment | Phase 2 | Recruiting | Drug: Alisertib | Small Cell Lung Cancer | 120 | 2027-10-30 | in 437 d | 2026-08-17 |
| Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 MutationsNCT01953926results2024-03-12Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ · Informed Consent Form: Breast ↗ · Informed Consent Form: Neratinib Monotherapy ↗ | Phase 2 | Terminatedsponsor's stated reason: The study was terminated to align with the sponsor's current development plans for neratinib. The decision was not based on any new efficacy or safety data for neratinib. | Drug: Neratinib, Fulvestrant, Trastuzumab, Paclitaxel | Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations | 582 | 2023-01-02actual | — | 2024-03-12 |
| A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With NeratinibNCT04366713results2023-02-10Changes in Colon PathologyOpen-label · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ · Informed Consent Form ↗ | Phase 2 | Completed | Drug: Neratinib, Capecitabine, Loperamide | HER2 Amplified Breast Cancer | 6 | 2021-12-28actual | — | 2023-02-10 |
| An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and LoperamideNCT02400476results2022-05-06Percentage of Patients With Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0.Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ · Informed Consent Form ↗ | Phase 2 | Completed | Drug: Neratinib, Loperamide, Colestipol, Budesonide | Early Stage HER2+ Breast Cancer | 563 | 2021-04-22actual | — | 2022-05-06 |
| HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of NeratinibNCT03786107observationalNumber of Participants Eligible for Neratinib Treatment | — | Terminatedsponsor's stated reason: The study was stopped early due to increased global access to genomic screening. It is no longer economical to continue with this particular single-gene screening protocol. | Diagnostic test: Almac HER-Seq Assay | Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer | 1,583 | 2021-01-21actual | — | 2021-05-19 |
| 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 SettingNCT01808573results2019-12-11Centrally Assessed Progression Free SurvivalRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: neratinib, capecitabine, lapatinib | HER2+ Metastatic Breast Cancer (MBC) | 621 | 2018-09-28actual | — | 2021-06-11 |
| Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung CancerNCT01827267results2017-09-11Objective Response Rate (ORR)Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: neratinib, temsirolimus | HER2-mutant Non-Small Cell Lung Cancer | 62 | 2016-09-20actual | — | 2018-07-03 |
| Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast CancerNCT01111825results2017-11-07Objective Response Rate (ORR) (Phase II)Open-label · Treatment | Phase 1/2 | Completed | Drug: Temsirolimus, Neratinib | Breast Cancer | 99 | Jul 2016actual | — | 2018-09-26 |
| Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy SubjectsNCT02334501AUC(0-t) of neratinib with and without lansoprazoleOpen-label | Phase 1 | Completed | Drug: Lansoprazole, Neratinib | Healthy | 15 | Oct 2014actual | — | 2016-05-11 |
| Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast CancerNCT00878709results2017-10-09Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: neratinib · Other: placebo | Breast Cancer | 2,840 | 2014-08-21actual | — | 2021-06-11 |
| Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast CancerNCT00915018results2017-11-06Progression-Free SurvivalRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: Neratinib, Trastuzumab, Paclitaxel | Breast Cancer | 479 | Aug 2013actual | — | 2018-08-22 |
| Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of NeratinibNCT00932464Pharmacokinetics as measured by AUC, Cmax, tmax, t1/2Randomized · Open-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: Study withdrawn as it no longer is deemed necessary per project status. | Drug: Neratinib, Neratinib | Healthy | 0 | Aug 2012 | — | 2012-05-14 |
| Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid TumorsNCT00838539results2018-02-26Probability of Dose-Limiting Toxicity (DLT)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Neratinib, Temsirolimus | Neoplasms, Malignant Carcinoma | 63 | Jun 2011actual | — | 2018-09-18 |
| A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast CancerNCT00445458results2018-05-09Dose Limiting Toxicity Incidence of Neratinib in Combination With PaclitaxelNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: HKI-272, Paclitaxel | Advanced Breast Cancer, Advanced Malignant Solid Tumors, Breast Neoplasms | 110 | May 2011actual | — | 2018-07-26 |
| Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast CancerNCT00777101results2017-11-09Progression Free SurvivalRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: Neratinib, Lapatinib, Capecitabine | Advanced Breast Cancer, Breast Cancer | 233 | Mar 2011actual | — | 2018-08-09 |
| A Study Of Neratinib (HKI-272) And Capecitabine In Japanese With Solid TumorNCT01128842results2018-12-19Dose Limiting Toxicity (DLT) - Percentage of Participants With DLT EventsOpen-label · Treatment | Phase 1 | Completed | Drug: Neratinib, Capecitabine | Advanced Malignant Solid Tumors | 7 | Mar 2011actual | — | 2018-12-19 |
| Study Evaluating Safety And Tolerability, Solid TumorNCT00768469results2018-11-19Dose Limiting Toxicity (DLT) - Percentage of Participants With DLT EventsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Neratinib, Paclitaxel | Advanced Malignant Solid Tumors | 10 | Jan 2011actual | — | 2018-11-19 |
| Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast CancerNCT00741260results2017-11-09Number of Participants With Dose Limiting ToxicitiesNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: Neratinib, Capecitabine | Breast Cancer | 105 | Nov 2010actual | — | 2018-09-05 |
| A Single Dose Bioequivalence Study Of Neratinib In Healthy SubjectsNCT01142063observationalMaximum plasma concentration (Cmax) and Area under the plasma concentration-time profile from time zero extrapolated to infinite time for neratinib (AUCinf) | — | Completed | Drug: Neratinib, Neratinib, Neratinib, Neratinib | Healthy | 28 | Sep 2010actual | — | 2012-05-14 |
| Study Evaluating Neratinib In Combination With Vinorelbine In Subjects With Advanced Or Metastatic Solid TumorsNCT00958724results2018-02-26Dose Limiting Toxicity (DLT)Open-label · Treatment | Phase 1 | Completed | Drug: Neratinib, Vinorelbine | Advanced Malignant Solid Tumors | 6 | Apr 2010actual | — | 2018-06-28 |
| Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver DiseaseNCT00781430Plasma concentrations of neratinib in healthy volunteers compared to hepatically impaired patients through analysis of blod samples collected after neratinib administration in these 2 populations.Non-randomized · Open-label | Phase 1 | Completed | Drug: Neratinib (HKI-272) | Hepatic Insufficiency | 27 | Feb 2010actual | — | 2012-05-14 |
| Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast CancerNCT00706030results2018-05-08Overall Response RateNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: neratinib, vinorelbine | Breast Cancer, Advanced Malignant Solid Tumors | 92 | Oct 2009actual | — | 2018-08-09 |
| A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast CancerNCT00398567results2018-04-1316-week Progression-free Survival (PFS) RateNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: HKI-272, trastuzumab | Advanced Breast Cancer | 45 | 2009-07-31actual | — | 2018-07-24 |
| Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of NeratinibNCT00864487Pharmacokinetics (plasma blood concentrations)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Neratinib | Healthy Subjects | 24 | May 2009actual | — | 2012-05-14 |
| Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of DigoxinNCT00860223Pharmacokinetic parameters: concentration of digoxin in blood and urineNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Digoxin, Neratinib | Healthy | 27 | Apr 2009actual | — | 2012-05-14 |
| A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid TumorsNCT00397046results2018-02-19Dose Limiting Toxicity (DLT)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: neratinib | Tumors | 21 | Mar 2009actual | — | 2018-09-14 |
| Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)NCT00814060Blood will be collected to determine the pharmacokinetics of the various formulations of HKI-272Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: neratinib | Healthy Subjects | 24 | Mar 2009actual | — | 2012-05-14 |
| Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung CancerNCT00266877results2018-04-13Objective Response Rate for Neratinib in Patients With Non-small Cell Lung CancerNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: HKI-272 | Carcinoma, Non-Small-Cell Lung, Lung Neoplasms | 172 | Jan 2009actual | — | 2018-04-13 |
| Study Evaluating The Tolerability Of Multiple Doses Of HKI-272NCT00757809Occurence of diarrheaRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: neratinib | Healthy Subjects | 50 | Oct 2008actual | — | 2012-05-14 |
| Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)NCT00708903QTc intervalRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: neratinib, Moxifloxacin · Other: Placebo | Breast Cancer | 60 | Jul 2008actual | — | 2012-05-14 |
| Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast CancerNCT00300781results2017-09-1316-week Progression Free SurvivalRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: neratinib | Breast Neoplasms, Neoplasms | 136 | Apr 2008actual | — | 2018-08-14 |
| Study Evaluating Oral Administrations of HKI-272 in Healthy Male SubjectsNCT00550212Mass balance, metabolic distribution, PKNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: neratinib | Healthy | 6 | Apr 2008actual | — | 2012-05-14 |
| Study Evaluating HKI-272 in TumorsNCT00146172results2018-02-13Dose Limiting Toxicity (DLT)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: neratinib | Breast Neoplasms | 73 | Jan 2007actual | — | 2018-09-17 |
| Study Evaluating HKI-272 Administered to Healthy SubjectsNCT00366600Pharmacokinetics; safety and tolerability; influence of food on the same.Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: neratinib | Healthy | 56 | Dec 2006actual | — | 2017-09-11 |
| HKI-272 Ketoconazole Drug Interaction StudyNCT00380328Pharmacokinetics; safety and tolerabilityRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: neratinib | Healthy | 24 | — | — | 2012-05-14 |
| Study Comparing 2 New Formulations of HKI-272 in Healthy Adult SubjectsNCT00498745The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development.Randomized · Open-label | Phase 1 | Completed | Drug: neratinib | Healthy | 36 | — | — | 2012-05-14 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19