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This study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK (pharmacokinetics) of oral AMG 900 in subjects with acute myeloid leukemia. Up to 93 subjects may be enrolled in dose escalation. The dose expansion part of the study will consist of 20 subjects with acute myeloid leukemia. The dose of AMG 900 will be dependent upon data from the dose escalation part of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1- Dose Escalation | Experimental | The dose escalation will be conducted in 2 parts. Group 1 will consist of 8 cohorts and Group 2 will consist of 5 cohorts. The dose escalation is aimed at determining the maximum tolerated dose (MTD) of AMG 900. |
|
| Arm 2- Dose Expansion | Experimental | The dose expansion part of the study will begin after completion of the dose escalation phase and will consist of 20 subjects with acute myelogenous leukemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1- Dose Escalation | Drug | AMG 900 is a small molecule aurora kinase inhibitor. AMG 900 will be administered daily for 4 days every 2 weeks or daily 7 days every 2 weeks (ie.g., 4 consecutive days of dosing followed by 10 consecutive days off treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Subject incidence of adverse events | 1 year | |
| Subject incidence of dose limiting toxicities (DLTs) | 1 year | |
| Maximum observed concentration of AMG 900 | 1 year | |
| Time to maximum observed concentration of AMG 900 | 1 year | |
| Area under the plasma concentration-time curve (AUC) of AMG 900 | 1 year | |
| Half life of AMG 900 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response as per Cheson Response Criteria | 1 year | |
| Change in the number of p-Histone H3 positive cells from baseline | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Other Inclusion/ Exclusion Criteria may apply to qualify for enrollment
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stony Brook | New York | 11794 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28370201 | Background | Kantarjian HM, Schuster MW, Jain N, Advani A, Jabbour E, Gamelin E, Rasmussen E, Juan G, Anderson A, Chow VF, Friberg G, Vogl FD, Sekeres MA. A phase 1 study of AMG 900, an orally administered pan-aurora kinase inhibitor, in adult patients with acute myeloid leukemia. Am J Hematol. 2017 Jul;92(7):660-667. doi: 10.1002/ajh.24736. Epub 2017 Jun 5. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| D007951 | Leukemia, Myeloid |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
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| Arm 2- Dose Expansion | Drug | AMG 900 is a small molecule aurora kinases inhibitor. The dose expansion phase would be conducted to gain further clinical experience with AMG 900 in AML at the optimal dose schedule. |
|
| Cleveland |
| Ohio |
| 44195 |
| United States |
| Research Site | Houston | Texas | 77030 | United States |