43 completed, 4 terminated, 3 recruiting, 2 active not recruiting. 32 Phase 1, 23 Phase 2, 1 Not applicable, 1 Phase 3.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+/HER2+ Breast Cancer Alisertib - HR+/HER2+ Breast Cancer, Metastatic Breast Cancer | Phase 2 | Not yet recruiting | University of Wisconsin, Madison | 10 | 2026-10-01 | 2026-09-29 |
| A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC) Alisertib, Paclitaxel - Small Cell Lung Cancer ( SCLC ) | Phase 2 | Recruiting | Puma Biotechnology, Inc. | 50 | 2026-09-17 | 2026-09-30 |
| A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer Alisertib, Endocrine therapy - Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer | Phase 2 | Recruiting | Puma Biotechnology, Inc. | 225 | 2024-11-19 | 2026-10-01 |
| A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer Alisertib - Small Cell Lung Cancer | Phase 2 | Recruiting | Puma Biotechnology, Inc. | 120 | 2024-02-08 | 2026-08-17 |
| Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer Alisertib, Pembrolizumab - Head and Neck Squamous Cell Carcinoma, Malignant Solid Neoplasm | Phase 1 / Phase 2 | Completed | M.D. Anderson Cancer Center | 24 | 2020-09-15 | 2025-05-20 |
| Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage IIIB or IV Non-Small Cell Lung Cancer Alisertib, Osimertinib, Sapanisertib - Recurrent Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8 | Phase 1 | Completed | M.D. Anderson Cancer Center | 37 | 2020-06-18 | 2026-04-16 |
| Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer Osimertinib, Alisertib - Lung Cancer Metastatic, EGFR Gene Mutation | Phase 1 | Completed | Collin Blakely | 23 | 2019-11-12 | 2026-08-11 |
| Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer Alisertib, Fulvestrant, Laboratory Biomarker Analysis - Estrogen Receptor Status, HER2/Neu Negative | Phase 2 | Completed | Mayo Clinic | 96 | 2017-07-06 | 2026-09-24 |
| A Phase I Study of Alisertib + R-EPOCH for Treatment of Myc-Positive Aggressive B-cell Lymphomas Alisertib - Diffuse Large B-cell Lymphoma, Follicular Lymphoma | Phase 1 | Terminated | UNC Lineberger Comprehensive Cancer Center | 1 | 2016-10-01 | 2017-11-20 |
| Alisertib and TAK-228 in Participants With Human Papilloma Virus (HPV) Associated Malignancies Alisertib, TAK-228 - Malignant Neoplasms of Digestive Organs, Malignant Neoplasms of Female Genital Organs | Phase 1 | Withdrawn | M.D. Anderson Cancer Center | 2016-09-01 | 2017-03-27 | |
| Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer Alisertib, MLN0128 - Metastatic Breast Cancer, Solid Tumors | Phase 1 | Completed | University of Colorado, Denver | 47 | 2016-05-13 | 2022-07-25 |
| Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML Alisertib, Cytarabine, Idarubicin - Acute Myeloid Leukemia | Phase 2 | Completed | Massachusetts General Hospital | 42 | 2015-12-01 | 2020-05-05 |
| MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma MLN1117, TAK-659, Alisertib - Advanced and Metastatic Gastric or Gastroesophageal Adenocarcinoma | Phase 1 | Terminated | Millennium Pharmaceuticals, Inc. | 32 | 2015-10-15 | 2019-09-20 |
| Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia Alisertib, Laboratory Biomarker Analysis, Pharmacological Study - Acute Megakaryoblastic Leukemia, Myelofibrosis | Not applicable | Unknown | Northwestern University | 26 | 2015-10-09 | 2021-05-26 |
| Alisertib and Combination Chemotherapy in Treating Patients With Gastrointestinal Tumors Alisertib, Fluorouracil, Laboratory Biomarker Analysis - Malignant Digestive System Neoplasm | Phase 1 | Completed | National Cancer Institute (NCI) | 14 | 2015-08-27 | 2018-10-09 |
| Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma Alisertib - Lung Cancer, Mesothelioma | Phase 2 | Completed | M.D. Anderson Cancer Center | 28 | 2015-05-20 | 2022-10-04 |
| Alisertib (MLN8237) in Combination With Weekly Paclitaxel in East Asian Patients With Advanced Solid Tumors Alisertib, Paclitaxel - Advanced Solid Tumors, Ovarian Cancer | Phase 1 | Terminated | Millennium Pharmaceuticals, Inc. | 9 | 2015-03-19 | 2019-06-26 |
| Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer Paclitaxel, Alisertib - Breast Cancer, Breast Carcinoma | Phase 2 | Completed | US Oncology Research | 169 | 2015-02-12 | 2024-10-09 |
| Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas Hyperfractionated radiation therapy, Stereotactic radiosurgery, Alisertib - Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma | Phase 1 | Completed | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | 17 | 2015-01-30 | 2025-04-30 |
| A Study MLN2480 in Combination With MLN0128 or Alisertib, or Paclitaxel, or Cetuximab, or Irinotecan in Adult Participants With Advanced Nonhematologic Malignancies MLN2480, MLN0128, Alisertib - Advanced Nonhematologic Malignancies | Phase 1 | Completed | Millennium Pharmaceuticals, Inc. | 81 | 2015-01-14 | 2020-02-25 |
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Breast Neoplasms (8) · Lymphoma (6) · Burkitt Lymphoma (5) · Lymphoma, Large B-Cell, Diffuse (5) · Lymphoma, Mantle-Cell (5) · Lymphoma, Follicular (4) · Lymphoma, T-Cell (4) · Small Cell Lung Carcinoma (4) · Immunoblastic Lymphadenopathy (3) · Leukemia, Myeloid, Acute (3) · Lymphoma, B-Cell (3) · Lymphoma, B-Cell, Marginal Zone (3) · Lymphoma, Large-Cell, Anaplastic (3) · Ovarian Neoplasms (3) · Prostatic Neoplasms (3)
Millennium Pharmaceuticals, Inc. (20) · National Cancer Institute (NCI) (7) · M.D. Anderson Cancer Center (4) · Puma Biotechnology, Inc. (3) · Children's Oncology Group (2) · Massachusetts General Hospital (2) · Mayo Clinic (2) · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University (2) · Collin Blakely (1) · Edward Kim (1) · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (1) · Northwestern University (1) · Ohio State University Comprehensive Cancer Center (1) · St. Jude Children's Research Hospital (1) · The University of Texas Health Science Center at San Antonio (1)
United States (48) · Spain (7) · Canada (4) · France (3) · Italy (3) · Belgium (2) · Czechia (2) · Germany (2) · Hungary (2) · Poland (2) · Portugal (2) · United Kingdom (2) · Australia (1) · Austria (1) · Belarus (1)
Amir Fathi, MD (2) · Amar Gajjar, MD (1) · Andrea Necchi, MD (1) · Anne S. Tsao, MD (1) · Arkadiusz Z. Dudek, M.D. (1) · Brady Stein, MD (1) · Catherine S Diefenbach (1) · Christopher Dittus, DO (1) · Collin Blakely, MD, PhD (1) · David Hyman (1)
PMID 34435684, PMID 17242396, PMID 24352795, PMID 26073352, PMID 26077240, PMID 26084989, PMID 26689566, PMID 26873642, PMID 27502708, PMID 28034990, PMID 28155045, PMID 28178640, PMID 30232224, PMID 30347019, PMID 30707661, PMID 30777875, PMID 30825962, PMID 30973373, PMID 31617432, PMID 31655296, PMID 31837959, PMID 33877311, PMID 33993383, PMID 36892847
2008 (2), 2014 (2), P30CA093373 (2), 2009 (1), 2015 (1), P30CA013330 (1), P30CA015083 (1), P30CA016359 (1), P30CA016672 (1), P30CA033572 (1), P30CA060553 (1), R01CA131225 (1), R01CA214893 (1), U01CA062461 (1), U01CA062505 (1)