DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)
|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: NCT03110354|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : September 14, 2018
This research study tests an investigational drug called DS-3201b. An investigational drug is a medication that is still being studied and has not yet been approved by the United States Food and Drug Administration (FDA). The FDA allows DS-3201b to be used only in research. It is not known if DS-3201b will work or not.
This study consists of two parts. The first part (Part 1) is a dose escalation that will enroll subjects with AML or ALL that did not respond or no longer respond to previous standard therapy. The purpose of Part 1 of this research study is to determine the highest dose a patient can tolerate or recommended dose of DS-3201b that can be given to subjects with AML or ALL. Once the highest tolerable dose is determined, additional subjects will be enrolled at that dose into Part 2 of the study.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute Leukemia, Lymphocytic, Acute||Drug: DS-3201b||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||A Phase 1 Study of DS-3201b in Subjects With Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)|
|Actual Study Start Date :||March 28, 2017|
|Estimated Primary Completion Date :||March 27, 2019|
|Estimated Study Completion Date :||March 27, 2019|
Experimental: DS-3201b in AML or ALL
DS-3201b is administered orally to participants with AML or ALL at a starting dose of 100 mg once a day, and then possibly at higher doses depending on safety observations
DS-3201b is supplied as 25 and 100 mg capsules packaged in high-density polyethylene (HDPE) bottles.
- Part 1: Number of participants with dose-limiting toxicities [ Time Frame: within 28 days ]Part 1 is the 28-day dose escalation part
- Part 2: Number of participants with dose-limiting toxicities [ Time Frame: within 2 years ]Part 2 is the dose expansion part
- Parts 1 and 2: Number of participants who experienced an adverse event during the trial [ Time Frame: within 2 years ]Adverse events are collected for the entire duration of study participation
- Maximum (peak) observed concentration (Cmax) [ Time Frame: within 8 days ]Cmax is the highest concentration of the drug in circulating plasma (blood) as observed on days 1-2 and 8 of each part's single 28-day pharmacokinetics (PK) cycle.
- Time to maximum observed concentration (Tmax) [ Time Frame: within 8 days ]Tmax is the time it takes for Cmax to be reached as observed on days 1-2 and 8 of each part's single 28-day PK cycle.
- Area under the curve up to the last quantifiable time (AUClast) [ Time Frame: within 8 days ]Area under the plasma concentration-time curve up to the last measurable concentration as observed on days 1-2 and 8 of each part's single 28-day PK cycle.
- Trough plasma concentration (Ctrough) [ Time Frame: within 2 years ]Trough concentration is the lowest concentration reached by a drug before the next dose is administered as observed Pre-dose on Days 2, 8, 15, 22 in the single 28-day cycle 1, day 1 of cycle 2 and End of Treatment
- Part 2: Number of participants with response to treatment [ Time Frame: within 2 years ]Response to treatment is defined per the revised International Working Group (IWG) response criteria for AML (Cheson 2003) or standard response criteria for ALL (NCCN 2016 ALL response 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): NCT03110354
|United States, Alabama|
|University of Alabama||Terminated|
|Birmingham, Alabama, United States, 35294|
|United States, Massachusetts|
|Massachusetts General Hospital||Active, not recruiting|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|University of Michigan||Not yet recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Principal Investigator 734-936-9814 firstname.lastname@example.org|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Principal Investigator 212-639-2194 email@example.com|
|United States, Tennessee|
|Vanderbilt University||Not yet recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Principal Investigator 615-936-8422 Michael.firstname.lastname@example.org|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Naval Daver, MD 713-794-4392 NDaver@mdanderson.org|
|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|