First in Human Study of KO-539 in Relapsed or Refractory 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04067336|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 17, 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).
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): NCT04067336
|Contact: Diana Hummelemail@example.com|
|Contact: Bridget Martell, MDfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 40411|
|Contact: E. Lela Lartey 312-695-1377 email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jeannette Pacheco 617-726-0759 firstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Hospitals||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Zakery Northrop 734-936-2635 email@example.com|
|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|