First in Human Study of KO-539 in Relapsed or Refractory Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04067336|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : June 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Neoplasm||Drug: KO-539||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO 539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia|
|Actual Study Start Date :||September 12, 2019|
|Estimated Primary Completion Date :||January 26, 2021|
|Estimated Study Completion Date :||June 26, 2021|
dose escalation study - capsules
- Determine the maximal tolerated dose (MTD) of KO-539 mono-therapy in 28-day cycles. [ Time Frame: DLTs will be evaluated during the first 28 days (1 cycle) of KO-539 mono-therapy ]MTD is defined as the highest dose that is not expected to cause dose limiting toxicity (DLT) in more than 20% of patients.
- Number of patients that experience Adverse Events (AEs) and Serious Adverse Events (SAEs). [ Time Frame: During treatment and up to approximately 28 days after treatment discontinuation, or until immediately before the initiation of another anticancer therapy, whichever occurs first. ]Adverse Events (AEs) and Serious Adverse Events (SAEs) will be graded according to the NCI-CTCAE v5.01.
- Maximum observed plasma concentration (Cmax) of KO-539. [ Time Frame: Blood samples for determination of KO-539 concentration will be collected in Cycle 1 and Cycle 2. Each cycle is 28 days. ]Determine Cmax of KO-539.
- Time to reach maximum observed concentration (Tmax). [ Time Frame: Blood samples for determination of KO-539 concentration will be collected in Cycle 1 and Cycle 2. Each cycle is 28 days. ]Determine Tmax of KO-539.
- Area under plasma-concentration time curve from time 0 to time of last quantifiable concentration (AUC(0-last)). [ Time Frame: Blood samples for determination of KO-539 concentration will be collected in Cycle 1 and Cycle 2. Each cycle is 28 days. ]Determine AUC(0-last) of KO-539.
- Early evidence of antitumor activity. [ Time Frame: Up to 6 months following end of treatment. ]Antitumor activity will be assessed according to the criteria proposed by the 2017 European Leukemia Network (ELN).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067336
|Contact: Diana Hummelfirstname.lastname@example.org|
|Contact: Bridget Martell, MDemail@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 40411|
|Contact: Ellie Nash 312-695-2273 firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Preethi Manohar email@example.com|
|United States, Michigan|
|University of Michigan Hospitals||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Zakery Northrop 734-936-2635 firstname.lastname@example.org|
|United States, New York|
|Roswell Park Comprehensive Cancer Center||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Anna Krasopoulos 716-845-1516 Anna.Krasopoulos@roswellpark.org|
|United States, Washington|
|Fred Hutchinson Cancer Research Center||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Kaysey Orlowski email@example.com|