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Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 232 | Experimental | AMG 232 is an anti-cancer agent |
|
| AMG 232 & Trametinib | Experimental | AMG 232 and Trametinib are anti cancer agents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 232 | Drug | Given an an oral tablet in escalating doses. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of AMG 232 | To evaluate the safety and tolerability of AMG 232 by reviewing clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled. | 36 months |
| Characterize the pharmacokinetics of AMG 232 alone and in combination with trametinib when administered orally. | PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax). | 36 months |
| Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible. | The MTD is defined at the highest dose level with an observed incidence of dose limiting toxicity in < 33% of subjects enrolled in a cohort. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response | Complete response (CR), complete response with incomplete recovery (CRi), and duration response. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31253596 | Derived | Erba HP, Becker PS, Shami PJ, Grunwald MR, Flesher DL, Zhu M, Rasmussen E, Henary HA, Anderson AA, Wang ES. Phase 1b study of the MDM2 inhibitor AMG 232 with or without trametinib in relapsed/refractory acute myeloid leukemia. Blood Adv. 2019 Jul 9;3(13):1939-1949. doi: 10.1182/bloodadvances.2019030916. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| Trametinib |
| Drug |
Trametinib is an oral tablet given in a fixed dose. |
|
| Buffalo |
| New York |
| 14263 |
| United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Salt Lake City | Utah | 84112 | United States |
| Research Site | Seattle | Washington | 98101 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C588087 | 2-(5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-(1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid |
| C560077 | trametinib |
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