Puma Biotechnology, Inc.
PBYIHealthcare|Biotechnology|US
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Clinical Trials (59)
| Trial | Conditions | Phase | Status | Enrollment | Design | Drug |
|---|---|---|---|---|---|---|
| NCT06369285 A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer | Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer | P2 | Recruiting | 225 | RCT, Open-label | Alisertib, Endocrine therapy |
| NCT06109467 Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer | GastroEsophageal Cancer, Gastric Cancer | P2 | Active | 8 | Open-label | Neratinib, Trastuzumab, Oxaliplatin, 5-Fluorouracil + leucovorin, Pembrolizumab |
| NCT05252988 Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib | Early-stage Breast Cancer, HER2 Positive Breast Cancer | P2 | Active | 177 | RCT, Open-label | Neratinib, Loperamide, Colesevelam |
| NCT05919108 Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers | Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer | P2 | Recruiting | 30 | RCT, Open-label | Neratinib |
| NCT06095505 A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer | Small Cell Lung Cancer | P2 | Recruiting | 120 | Open-label | Alisertib |
| NCT04886531 Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers | Breast Cancer, HER2-positive Breast Cancer | P2 | Recruiting | 30 | Open-label | Neratinib, Letrozole (L) or Anastrozole (A), Trastuzumab |
| NCT02977780 INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) | Glioblastoma | P2 | Recruiting | 460 | RCT, Open-label | Temozolomide, Neratinib, QBS10072S, Abemaciclib, CC-115 |
| NCT07465757 A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC) | Small Cell Lung Cancer ( SCLC ) | P2 | Recruiting | 50 | Open-label | Alisertib, Alisertib, Alisertib, Alisertib, Alisertib, Paclitaxel |
| NCT05274048 Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients | Gastric Cancer, Gastrointestinal Cancer | P1 | Recruiting | 18 | Open-label | Neratinib Pill, Fam-Trastuzumab Deruxtecan-Nxki (TDxD) |
| NCT04502602 Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer | Advanced Solid Tumor, Ovarian Cancer | P1 | Active | 18 | Open-label | Neratinib 160 mg, Neratinib 200 mg, Neratinib 240 mg, Niraparib 100 mg, Niraparib 200 mg, Niraparib 300 mg, Niraparib at RP2D, Neratinib at RP2D |
| NCT00878709 Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer | Breast Cancer | P3 | Completed | 2,840 | RCT, Double-blind | neratinib |
| NCT01808573 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 | HER2+ Metastatic Breast Cancer (MBC) | P3 | Completed | 621 | RCT, Open-label | neratinib, capecitabine, lapatinib |
| NCT01111825 Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer | Breast Cancer | P1P2 | Completed | 99 | Open-label | Temsirolimus, Neratinib |
| NCT03919292 Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca | Solid Tumor, Adult | P1P2 | SUSPENDED | 80 | Open-label | Neratinib, Divalproex Sodium |
| NCT01008150 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 | Breast Cancer | P2 | Completed | 141 | RCT, Open-label | Paclitaxel, Trastuzumab, Neratinib, Doxorubicin, Cyclophosphamide |
| NCT02236000 A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer | Breast Cancer | P1P2 | Completed | 49 | Open-label | Neratinib, T-DM1 |
| NCT00266877 Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer | Carcinoma, Non-Small-Cell Lung, Lung Neoplasms | P2 | Completed | 172 | Open-label | HKI-272 |
| NCT04781374 Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer | Metastatic Prostate Adenocarcinoma, Castration-resistant Prostate Cancer | P2 | Withdrawn | — | Open-label | Neratinib |
| NCT01494662 HKI-272 for HER2-Positive Breast Cancer and Brain Metastases | Breast Cancer | P2 | Completed | 140 | Open-label | HKI-272, Capecitabine, HKI-272, Ado-Trastuzumab Emtansine |
| NCT00915018 Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer | Breast Cancer | P2 | Completed | 479 | RCT, Open-label | Neratinib, Trastuzumab, Paclitaxel |
| NCT03812393 Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast | Triple Negative Breast Cancer, Early-stage Breast Cancer | P2 | Unknown | 27 | Open-label | Neratinib |
| NCT01953926 Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations | Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations | P2 | Terminated | 582 | Open-label | Neratinib, Fulvestrant, Trastuzumab, Paclitaxel |
| NCT00300781 Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer | Breast Neoplasms, Neoplasms | P2 | Completed | 136 | RCT, Open-label | neratinib |
| NCT01670877 Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer | Breast Neoplasms | P2 | Completed | 56 | Open-label | Neratinib, Fulvestrant, Trastuzumab |
| NCT02400476 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 | Early Stage HER2+ Breast Cancer | P2 | Completed | 563 | Open-label | Neratinib, Loperamide, Colestipol, Budesonide |
| NCT03457896 Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status | Metastatic Colorectal Cancer | P2 | Unknown | 35 | Open-label | Trastuzumab, Cetuximab, Neratinib |
| NCT04901299 Fulvestrant + Neratinib In Breast Cancer | Stage IV (Metastatic) Breast Cancer, Metastatic Breast Cancer | P2 | Withdrawn | — | Open-label | NERATINIB, FULVESTRANT |
| NCT00741260 Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer | Breast Cancer | P1P2 | Completed | 105 | Open-label | Neratinib, Capecitabine |
| NCT03289039 Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer | Breast Cancer | P2 | Terminated | 21 | RCT, Open-label | Neratinib, Fulvestrant |
| NCT00777101 Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer | Advanced Breast Cancer, Breast Cancer | P2 | Completed | 233 | RCT, Open-label | Neratinib, Lapatinib, Capecitabine |
| NCT00445458 A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer | Advanced Breast Cancer, Advanced Malignant Solid Tumors | P1P2 | Completed | 110 | Open-label | HKI-272, Paclitaxel |
| NCT01827267 Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer | HER2-mutant Non-Small Cell Lung Cancer | P2 | Completed | 62 | RCT, Open-label | neratinib, temsirolimus |
| NCT05243641 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 | Metastatic Breast Cancer, Breast Cancer | P1P2 | Terminated | 10 | Open-label | Neratinib, Capmatinib |
| NCT03377387 Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer | Breast Cancer | P1P2 | Completed | 34 | Open-label | Capecitabine, Neratinib |
| NCT04366713 A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib | HER2 Amplified Breast Cancer | P2 | Completed | 6 | Open-label | Neratinib, Capecitabine, Loperamide |
| NCT03094052 Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib | HER2-positive Breast Cancer, Breast Adenocarcinoma | P2 | Completed | 11 | Open-label | Neratinib, Trastuzumab, Loperamide, Crofelemer, Diphenoxylate/Atropine |
| NCT00706030 Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer | Breast Cancer, Advanced Malignant Solid Tumors | P1P2 | Completed | 92 | Open-label | neratinib, vinorelbine |
| NCT00398567 A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer | Advanced Breast Cancer | P1P2 | Completed | 45 | Open-label | HKI-272, trastuzumab |
| NCT00838539 Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors | Neoplasms, Malignant Carcinoma | P1 | Completed | 63 | Open-label | Neratinib, Temsirolimus |
| NCT00860223 Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin | Healthy | P1 | Completed | 27 | Open-label | Digoxin, Neratinib |
| NCT04085315 Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer | Lung Cancer Metastatic, EGFR Gene Mutation | P1 | Completed | 23 | Open-label | Osimertinib, Alisertib |
| NCT00781430 Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease | Hepatic Insufficiency | P1 | Completed | 27 | Open-label | Neratinib (HKI-272) |
| NCT00768469 Study Evaluating Safety And Tolerability, Solid Tumor | Advanced Malignant Solid Tumors | P1 | Completed | 10 | Open-label | Neratinib, Paclitaxel |
| NCT00380328 HKI-272 Ketoconazole Drug Interaction Study | Healthy | P1 | Completed | 24 | RCT, Open-label | neratinib |
| NCT00814060 Study Evaluating TwoTablet Formulations of Neratinib (HKI-272) | Healthy Subjects | P1 | Completed | 24 | RCT, Open-label | neratinib |
| NCT00864487 Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib | Healthy Subjects | P1 | Completed | 24 | Open-label | Neratinib |
| NCT00366600 Study Evaluating HKI-272 Administered to Healthy Subjects | Healthy | P1 | Completed | 56 | RCT, Open-label | neratinib |
| NCT00932464 Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib | Healthy | P1 | Withdrawn | — | RCT, Open-label | Neratinib, Neratinib |
| NCT00958724 Study Evaluating Neratinib In Combination With Vinorelbine In Subjects With Advanced Or Metastatic Solid Tumors | Advanced Malignant Solid Tumors | P1 | Completed | 6 | Open-label | Neratinib, Vinorelbine |
| NCT00550212 Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects | Healthy | P1 | Completed | 6 | Open-label | neratinib |
| NCT00146172 Study Evaluating HKI-272 in Tumors | Breast Neoplasms | P1 | Completed | 73 | Open-label | neratinib |
| NCT02334501 Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects | Healthy | P1 | Completed | 15 | Open-label | Lansoprazole, Neratinib |
| NCT00708903 Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization) | Breast Cancer | P1 | Completed | 60 | RCT, Double-blind | neratinib, Moxifloxacin |
| NCT00397046 A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors | Tumors | P1 | Completed | 21 | Open-label | neratinib |
| NCT01128842 A Study Of Neratinib (HKI-272) And Capecitabine In Japanese With Solid Tumor | Advanced Malignant Solid Tumors | P1 | Completed | 7 | Open-label | Neratinib, Capecitabine |
| NCT00498745 Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects | Healthy | P1 | Completed | 36 | RCT, Open-label | neratinib |
| NCT00757809 Study Evaluating The Tolerability Of Multiple Doses Of HKI-272 | Healthy Subjects | P1 | Completed | 50 | RCT, Double-blind | neratinib |
| NCT03786107 HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib | Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer | Terminated | 1,583 | — | — | |
| NCT01142063 A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects | Healthy | Completed | 28 | — | Neratinib, Neratinib, Neratinib, Neratinib |