SEL24 in Patients With AML
|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: NCT03008187|
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : March 12, 2018
Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of SEL24 in patients with AML.
At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2.
In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients who are unfit to receive intensive chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: SEL24||Phase 1 Phase 2|
This is a Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of SEL24 in patients with AML. At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2. In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients who are unfit to receive intensive chemotherapy.
Part 1 will commence with an accelerated dose escalation design for the first 4 cohorts. The study will then follow a 3+3 design from Cohort 5 onwards in order to provide adequate PK profile data. In Part 1 the MTD is defined as the highest dose at which no more than 1 in up to 6 patients experience a DLT during Cycle 1. The dose escalation rules to be followed during Part 1 of the study are described in the study protocol.
The highest SEL24 dose level considered to be well tolerated in 6 patients, and to have optimal PK and PD characteristics, will be called the RD and will be selected for further evaluation in Part 2.
Part 2 will enroll patients at the RD identified in Part 1. The treatment groups in Part 2 will be opened for recruitment based on recommendation by the Investigators, Medical Monitor and Sponsor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||May 2020|
SEL24 will be taken orally once daily for 14 consecutive days over a 21-day treatment cycle. The cohort dose may be escalated by an increase in the daily dose level during the study based on the dose escalation rules.
Continuation of the study treatment may be discussed between the investigator and the Sponsor on a case by case basis. The DMC may also advise on the suitability of an individual patient to continue to receive study treatment.
Patients who experience a DLT will be permitted to receive further treatment with SEL24 according to the dose modification rules described in the study protocol.
SEL24 taken orally once daily for 14 consecutive days over a 21-day treatment cycle.
Part 1 will commence with an accelerated dose escalation design. Part 2 will enroll patients at the recommended dose identified in Part 1.
Other Name: SEL24-B489
- Dose limiting toxicity (DLT) evaluation [ Time Frame: DLTs in patients during their first 21-day treatment cycle ]Maximum tolerated dose (MTD) or maximum administered dose (MAD) estimate
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): NCT03008187
|Contact: Ireneusz Otulski, MD||+48 608 firstname.lastname@example.org|
|Contact: Laurie Ford Graham, RN, MSNemail@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|Contact: Scott R Solomon, MD 404-255-1930 firstname.lastname@example.org|
|Contact: Stacey Brown 404-851-8238 email@example.com|
|Principal Investigator: Scott R Solomon, MD|
|United States, Ohio|
|Cleveland Clinic, Taussig Cancer Institute||Not yet recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Aziz Nazha, MD 713-792-2121 firstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Stephen A Strickland Jr, MD, MSCI 615-936-8422 email@example.com|
|Principal Investigator: Stephen A Strickland Jr, MD, MSCI|
|Sub-Investigator: Michael R Savona, MD|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Farhad Ravandi, MD 713-745-0394 firstname.lastname@example.org|
|Principal Investigator: Farhad Ravandi, MD|
|United States, Washington|
|Fred Hutchinson Cancer Research Center||Not yet recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Roland B Walter, MD|
|Contact (206) 667-3599 email@example.com|
|Principal Investigator:||Farhad Ravandi, MD||Department of Leukemia, MDACC|