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To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
| |
| Arm C | Experimental |
| |
| Arm D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM201 | Drug |
| ||
| ancillary treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) | DLTs in the first cycle of treatment. | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events (AEs) | Number of patients with AEs as a measure of Safety and tolerability of HDM201 single agent. | For the duration of treatment, an average of 16 weeks |
| Pharmacokinetics (PK) parameters of HDM201 |
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Inclusion Criteria:
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria 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-6 | Boston | Massachusetts | 02215 | United States | ||
| Memorial Sloan Kettering Onc. Dep |
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| Label | URL |
|---|---|
| Study Results | View source |
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| Drug |
|
| Up to 42 days |
| Changes from baseline of Pharmacodynamics markers | Baseline, up to 28 days |
| Tumor response | end of treatment = 1 year | Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment |
| New York |
| New York |
| 10017 |
| United States |
| Novartis Investigative Site | Lyon | 69373 | France |
| Novartis Investigative Site | Paris | 75010 | France |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0017 | Japan |
| Novartis Investigative Site | Chuo Ku | Tokyo | 104 0045 | Japan |
| Novartis Investigative Site | Amsterdam | 1066 CX | Netherlands |
| Novartis Investigative Site | Utrecht | 3584CX | Netherlands |
| Novartis Investigative Site | Singapore | 169610 | Singapore |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Taipei | Taiwan ROC | 10041 | Taiwan |
| ID | Term |
|---|---|
| C000654196 | siremadlin |
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