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A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDH305 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDH305 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incident rate of dose limiting toxicities (DLTs) | To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE) | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | To characterize the safety and tolerability of IDH305 | 30 months |
| Plasma PK parameters (AUC, Cmax, Tmax) | To characterize the PK profile of IDH305 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute SC (1) | Boston | Massachusetts | 02115 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35353219 | Derived | DiNardo CD, Hochhaus A, Frattini MG, Yee K, Zander T, Kramer A, Chen X, Ji Y, Parikh NS, Choi J, Wei AH. A phase 1 study of IDH305 in patients with IDH1R132-mutant acute myeloid leukemia or myelodysplastic syndrome. J Cancer Res Clin Oncol. 2023 Mar;149(3):1145-1158. doi: 10.1007/s00432-022-03983-6. Epub 2022 Mar 30. |
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| 30 months |
| Changes of 2-hydroxyglutarate concentration in patient specimens | To characterize the PD profile of IDH305 | 30 months |
| Overall response rate (ORR) | To assess any preliminary anti-tumor activity of IDH305 | 30 months |
| Incidence of serious adverse events (SAE) | To characterize the safety and tolerability of IDH305 | 30 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Columbia University Medical Center- New York Presbyterian Onc Dept. | New York | New York | 10032 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Uni Of TX MD Anderson Cancer Cntr | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Melbourne | Victoria | 3004 | Australia |
| Novartis Investigative Site | Parkville | Victoria | 3050 | Australia |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Novartis Investigative Site | Jena | Thuringia | 07740 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Rotterdam | South Holland | 3015 GD | Netherlands |
| ErasmusMC Cancer lnstitute, Neuro-Oncology, Rm G3-55 | Rotterdam | 3075 EA | Netherlands |
| Novartis Investigative Site | Singapore | 168583 | Singapore |
| Novartis Investigative Site | Barcelona | 08035 | Spain |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D005910 | Glioma |
| D009837 | Oligodendroglioma |
| D001254 | Astrocytoma |
| D005909 | Glioblastoma |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
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