Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01380756|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Hematologic Malignancies Leukemia Myeloid Leukemia||Drug: Arm 1- Dose Escalation Drug: Arm 2- Dose Expansion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia|
|Actual Study Start Date :||October 4, 2011|
|Actual Primary Completion Date :||September 4, 2014|
|Actual Study Completion Date :||September 4, 2014|
Experimental: Arm 1- Dose Escalation
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.
Drug: Arm 1- Dose Escalation
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).
Experimental: Arm 2- Dose Expansion
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.
Drug: Arm 2- Dose Expansion
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.
- Subject incidence of adverse events [ Time Frame: 1 year ]
- Subject incidence of dose limiting toxicities (DLTs) [ Time Frame: 1 year ]
- Maximum observed concentration of AMG 900 [ Time Frame: 1 year ]
- Time to maximum observed concentration of AMG 900 [ Time Frame: 1 year ]
- Area under the plasma concentration-time curve (AUC) of AMG 900 [ Time Frame: 1 year ]
- Half life of AMG 900 [ Time Frame: 1 year ]
- Objective response as per Cheson Response Criteria [ Time Frame: 1 year ]
- Change in the number of p-Histone H3 positive cells from baseline [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380756
|United States, New York|
|Stony Brook, New York, United States, 11794|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|Houston, Texas, United States, 77030|