Evaluation of KX2-391 in Elderly Subjects With Acute Myeloid Leukemia (AML)
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|ClinicalTrials.gov Identifier: NCT01397799|
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : December 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia||Drug: KX2-391||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Rising Multiple-Dose Study to Evaluate Safety, Tolerability and Activity of KX2-391 in Elderly Subjects With Acute Myeloid Leukemia Who Are Refractory to or Have Declined Standard Induction Therapy|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Subjects will be enrolled into a 28-day dose-escalation study. If no DLT's are observed during the first 28 days, subjects are eligible to continue treatment in the Extension Phase and can remain on treatment until toxicity occurs or until disease progression.
Oral dose solution, once-daily dosing for 28-days. Subjects may continue beyond the first 28-days until disease progression or unacceptable toxicity develops.
Other Name: KX01
- To determine the maximum tolerated dose of KX2-391 when given once-daily to AML patients. [ Time Frame: 28 days ]The MTD will be used to determine the recommended Phase 2 dose that is associated with an approximately 33% DLT rate during the first 28 days of treatment in elderly patients with AML
- Evaluate pharmacokinetics, pharmacodynamics and activity of KX2-391. [ Time Frame: 28 days ]The pharmacokinetics and pharmacodynamics of KX2-391 will be evaluated in AML patients by measuring serum and bone marrow levels of drug and evaluating the disruption of microtubule networks in these samples to determine whether target inhibition has occurred at the doses tested. Hematological and bone marrow response will be assessed according to International Working Group (IWG)-AML criteria.
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): NCT01397799
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||James Thompson, MD||Roswell Park Cancer Institute|