Table 1.
List of MDM2-p53 inhibitors in completed clinical trials
| Drug | Disease | Combination with | Action | Phase | Status | Trial nr | Sponzor | Time |
|---|---|---|---|---|---|---|---|---|
| RG7112 (RO5045337) | Advanced solid tumors | I | Completed | NCT00559533* | Hoffmann-LaRoche | 2007–2012 | ||
| Hematologic neoplasm | I | Completed | NCT00623870* | Hoffmann-La Roche | 2008–2012 | |||
| Solid tumors | I | Completed | NCT01164033* | Hoffmann-La Roche | 2010–2013 | |||
| Sarcoma | Doxorubicin | DNA damage | Ib | Completed | NCT01605526* | Hoffmann-La Roche | 2012–2013 | |
| Acute myelogenous leukemia (AML) | Cytarabine | DNA damage | Ib | Completed | NCT01635296* | Hoffmann-La Roche | 2012–2013 | |
| Extension study of studies marked with* | I | Completed | NCT01677780 | Hoffmann-La Roche | 2012–2017 | |||
| Idasanutlin (RG7388) | Advanced malignancies, except leukemia | I | Completed | NCT01462175 | Hoffmann-La Roche | 2011–2014 | ||
| Solid tumors | I | Completed | NCT03362723 | Hoffmann-La Roche | 2017–2019 | |||
| Acute myelogenous leukemia |
Idarubicin Daunorubicin Cytarabine |
DNA damage DNA damage DNA damage |
I/Ib | Completed | NCT01773408 | Hoffmann-La Roche | 2013–2016 | |
| Relapsed and refractory AML | Cytarabine | DNA damage | III | Terminated | NCT02545283 | Hoffmann-La Roche | 2012–2020 | |
| Non-Hodgkin’s lymphoma |
Obinutuzumab Rituximab |
Anti-CD20 Anti-CD20 |
I/Ib | Terminated | NCT02624986 | Hoffmann-La Roche | 2015–2019 | |
| Relapsed and refractory AML | Venetoclax | BCL-2 inhibitor | Ib | Completed | NCT02670044 | Hoffmann-La Roche | 2016–2020 | |
| Relapsed and refractory follicular lymphoma, relapsed and refractory diffuse large B-cell lymphoma |
Obinutuzumab Venetoclax Rituximab |
Anti-CD20 BCL-2 inhibitor Anti-CD20 |
Ib/II | Terminated | NCT03135262 | Hoffmann-La Roche | 2018–2020 | |
| Acute myelogenous leukemia |
Cytarabine Daunorubicin |
DNA damage DNA damage |
Ib/II | Completed | NCT03850535 | Hoffmann-La Roche | 2019–2020 | |
| AMG-232 (KRT-232) | Advanced solid tumors, multiple myeloma | I | Completed | NCT01723020 | Amgen | 2012–2017 | ||
| Acute myelogenous leukemia | Trametinib | MEK inhibitor | I | Completed | NCT02016729 | Kartos Therapeutics, Inc. | 2014–2017 | |
| Metastatic melanoma |
Trametinib Dabrafenib |
MEK inhibitor BRAF inhibitor |
Ib/IIa | Completed | NCT02110355 | Kartos Therapeutics, Inc. | 2014–2018 | |
|
APG-115 (AA-115) |
Advanced solid tumors. Lymphomas | I | Completed | NCT02935907 | Ascentage Pharma Group, Inc. | 2016–2019 | ||
| CGM097 | Advanced solid tumors with TP53wt | I | Completed | NCT01760525 | Novartis Pharmaceuticals | 2013–2019 | ||
| HDM201 | Liposarcoma | Ribociclib | CDKinhibitor | Ib/II | Completed | NCT02343172 | Novartis Pharmaceuticals | 2015–2019 |
| DS-3032b (Milademetan) | Advanced solid tumors, lymphomas | I | Completed | NCT01877382 | Daiichi Sankyo Co., Ltd. | 2013–2020 | ||
| Relapsed and refractory AML | I | Completed | NCT03671564 | Daiichi Sankyo Co., Ltd. | 2018–2019 | |||
| Acute myelogenous leukemia | Quizartinib | Tyrosine kinase inhibitor | I | Terminated | NCT03552029 | Daiichi Sankyo Co., Ltd. | 2018–2021 | |
| Acute myelogenous leukemia, myelodysplastic syndromes | 5-Azacitidine | DNA damage | I | Terminated | NCT02319369 | Daiichi Sankyo Co., Ltd. | 2014–2021 | |
| ALRN-6924 | Advanced solid tumors, lymphomas | I/IIa | Completed | NCT02264613 | Aileron Therapeutics | 2014–2020 | ||
| Acute myelogenous leukemia, myelodysplastic syndromes | Cytarabine | DNA damage | I/Ib | Completed | NCT02909972 | Aileron Therapeutics | 2016–2019 | |
| JNJ-26854165 | Advanced of refractory solid tumors | Completed | NCT00676910 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 2006–2010 | |||
| SAR405838 | Solid tumors | Pimasertib | MEK inhibitor | I | Completed | NCT01985191 | Sanofi | 2013–2016 |
*These studies were extended by clinical trial NCT01677780