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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 : September 1, 2021
Sponsor:
Collaborators:
Medpace, Inc.
Theradex
Information provided by (Responsible Party):
Menarini Group

Study Description
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Brief Summary:
The purpose of the clinical trial is to identify the maximum tolerated dose of SEL24/MEN1703 and to further investigate its safety profile 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 relapsed/refractory Acute Myeloid Leukemia, either all comers as well as harboring IDH1/IDH2 mutations.

Patients participating to the clinical trial will take the study drug as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: N/A
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 : March 10, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 in 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.
 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


Outcome Measures
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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


Secondary Outcome Measures :
  1. Safety profile of single agent SEL24/MEN1703 [ Time Frame: From Cycle 1 Day 1 to Final Study Visit (up to 30 days after last administered dose). Each Cycle lasts 21 days. ]
    Number and frequency of AEs


Eligibility Criteria
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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, all comers (completed) and bearing IDH1 or IDH2 mutation (open for recruitment)
  • Patient has no standard therapeutic options available and has either Relapsed AML unsuitable for intensive chemotherapy and not eligible for any approved targeted therapy or Primary refractory AML unsuitable for intensive chemotherapy and not eligible for any approved targeted therapy

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)
Contacts and Locations
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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
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Contact: Simone Baldini, MD +39 345 922 0957 SBaldini@menarini-ricerche.it

Locations
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Sponsors and Collaborators
Menarini Group
Medpace, Inc.
Theradex
Investigators
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Principal Investigator: Farhad Ravandi, MD Department of Leukemia, MDACC
More Information
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Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT03008187    
Other Study ID Numbers: CLI24-001
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Menarini Group:
AML
Relapsed/Refractory Acute Myeloid Leukemia
IDH
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms