A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
|ClinicalTrials.gov Identifier: NCT00916227|
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : December 30, 2014
This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug, given either with food or without food, in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 60 patients from the US will be enrolled in Part 1 (Completed).
In the second part of this study, patients will receive the best dose of study drug, given either with food or without food, determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Completed).
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Drug: ARRY-614, p38/Tie2 inhibitor; oral||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||January 2012|
Drug: ARRY-614, p38/Tie2 inhibitor; oral
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
- Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 1, one year; Part 2, one year ]
- Establish the maximum tolerated dose (MTD) of the study drug. [ Time Frame: Part 1, one year ]
- Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions. [ Time Frame: Part 1, one year; Part 2, one year ]
- Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement. [ Time Frame: Part 1, one year; Part 2, one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916227
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|