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SEL24/MEN1703 in Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT03008187
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
Medpace, Inc.
Theradex
Information provided by (Responsible Party):
Menarini Group

Brief Summary:
The purpose of the clinical trial is to identify the highest dose of SEL24/MEN1703 drug with acceptable safety profile and that can be used in patients with Acute Myeloid Leukemia.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: SEL24/MEN1703 Phase 1 Phase 2

Detailed Description:

Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum tolerated dose of SEL24/MEN1703 in patients with Acute Myeloid Leukemia.

The clinical trial will investigate the safety profile and anti-leukemic activity of SEL24/MEN1703 in patients with Acute Myeloid Leukemia and that have no standard therapeutic options available.

The clinical trial encompasses two parts:

  • Part 1, ascending dose levels: the main purpose of this part of the clinical trial is to determine the highest dose of SEL24/MEN1703 considered to be well tolerated.
  • Part 2, expansion cohort: the main purpose of this part of the clinical trial is to assess the safety and anti-leukemia activity of SEL24/MEN1703 given at the highest tolerated dose in patient with Acute Myeloid Leukemia.

Patients participating to the clinical trial will take the study drug as oral capsules once every 14 days over 21-day cycle.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : February 2019
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: SEL24/MEN1703

SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

  • Part 1: ascending dose levels (cohort) will be tested at least 3 patients. Any cohort in which 1 patient experiences a dose-limiting toxicity will be expanded up to 6 patients.
  • Part 2: testing at the dose of SEL24/MEN1703 which have demonstrated to be adequately tolerated in Part 1. SEL24/MEN1703 will be tested in four groups.
Drug: SEL24/MEN1703
SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.
Other Names:
  • SEL24-B489
  • MEN1703




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with diagnosis of Acute Myeloid Leukemia
  • patients has no standard therapeutic options (newly diagnosed Acute Myeloid Leukemia; Relapsed Acute Myeloid Leukemia ans Primary Refractory Acute Myeloid Leukemia).

Exclusion Criteria:

  • anti-cancer treatments (including cytotoxic chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy or investigational drugs) received within 14 days or 5 half-lives for targeted therapies (whichever is shorter) before first dose of study drug (to be supplemented)

Information from the National Library of Medicine

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


Contacts
Contact: Simone Baldini, MD +39 345 922 0957 SBaldini@menarini-ricerche.it
Contact: Benjamin Opperman +1 (513) 579-9911 ext 12539 b.opperman@medpace.com

Locations
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Scott R Solomon, MD    404-255-1930    ssolomon@bmtga.com   
Contact: Stacey Brown    404-851-8238    stacey.brown@northside.com   
Principal Investigator: Scott R Solomon, MD         
United States, Ohio
Cleveland Clinic, Taussig Cancer Institute Recruiting
Cleveland, Ohio, United States, 44195
Contact: Aziz Nazha, MD    713-792-2121    nazhaa@ccf.org   
United States, Tennessee
Vanderbilt Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Stephen A Strickland Jr, MD, MSCI    615-936-8422    stephen.strickland@vanderbilt.edu   
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    fravandi@mdanderson.org   
Principal Investigator: Farhad Ravandi, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Roland B Walter, MD         
Contact    (206) 667-3599    rwalter@fredhutch.org   
Sponsors and Collaborators
Menarini Group
Medpace, Inc.
Theradex
Investigators
Principal Investigator: Farhad Ravandi, MD Department of Leukemia, MDACC

Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT03008187     History of Changes
Other Study ID Numbers: CLI24-001
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Menarini Group:
AML
Relapsed/Refractory Acute Myeloid Leukemia
CD25
FLT3 mutation

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms