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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 : October 4, 2019
Sponsor:
Collaborators:
Medpace, Inc.
Theradex
Information provided by (Responsible Party):
Menarini Group

Tracking Information
First Submitted Date  ICMJE December 10, 2016
First Posted Date  ICMJE January 2, 2017
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03008187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SEL24/MEN1703 in Patients With Acute Myeloid Leukemia
Official Title  ICMJE A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia
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.
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 daily for 14 consecutive days over a 21-day treatment cycle.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: SEL24/MEN1703
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 30, 2016)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03008187
Other Study ID Numbers  ICMJE CLI24-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Menarini Group
Study Sponsor  ICMJE Menarini Group
Collaborators  ICMJE
  • Medpace, Inc.
  • Theradex
Investigators  ICMJE
Principal Investigator: Farhad Ravandi, MD Department of Leukemia, MDACC
PRS Account Menarini Group
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP