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SEL24/MEN1703 in Patients With Acute Myeloid Leukemia

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SEL24/MEN1703
Sponsored by
Menarini Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, Relapsed/Refractory Acute Myeloid Leukemia, IDH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northside Hospital
  • Cleveland Clinic, Taussig Cancer Institute
  • Oregon Health and Science University
  • Vanderbilt Ingram Cancer Center
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • MD Anderson Cancer Center
  • Fred Hutchinson Cancer Research Center
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Istituto Clinico Humanitas
  • ASST Monza - Ospedale San Gerardo
  • Institute of Haematology and Blood Transfusion
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii z Pododdzialem Chemioterapi
  • Institut Català d'Oncologia
  • Hospital 12 de Octubre
  • Hospital Universitari i Politecnic La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SEL24/MEN1703

Arm Description

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.

Outcomes

Primary Outcome Measures

Dose limiting toxicity (DLT) evaluation
Maximum tolerated dose (MTD) or maximum administered dose (MAD) estimate

Secondary Outcome Measures

Safety profile of single agent SEL24/MEN1703
Number and frequency of AEs

Full Information

First Posted
December 10, 2016
Last Updated
May 23, 2023
Sponsor
Menarini Group
Collaborators
Medpace, Inc., Theradex
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1. Study Identification

Unique Protocol Identification Number
NCT03008187
Brief Title
SEL24/MEN1703 in Patients With Acute Myeloid Leukemia
Official Title
A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
May 11, 2023 (Actual)
Study Completion Date
May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menarini Group
Collaborators
Medpace, Inc., Theradex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML, Relapsed/Refractory Acute Myeloid Leukemia, IDH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEL24/MEN1703
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
SEL24/MEN1703
Other Intervention Name(s)
SEL24-B489, MEN1703
Intervention Description
SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.
Primary Outcome Measure Information:
Title
Dose limiting toxicity (DLT) evaluation
Description
Maximum tolerated dose (MTD) or maximum administered dose (MAD) estimate
Time Frame
DLTs in patients during their first 21-day treatment cycle
Secondary Outcome Measure Information:
Title
Safety profile of single agent SEL24/MEN1703
Description
Number and frequency of AEs
Time Frame
From Cycle 1 Day 1 to Final Study Visit (up to 30 days after last administered dose). Each Cycle lasts 21 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhad Ravandi, MD
Organizational Affiliation
Department of Leukemia, MDACC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Cleveland Clinic, Taussig Cancer Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Milano
Country
Italy
Facility Name
ASST Monza - Ospedale San Gerardo
City
Monza
Country
Italy
Facility Name
Institute of Haematology and Blood Transfusion
City
Warsaw
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii z Pododdzialem Chemioterapi
City
Łódź
Country
Poland
Facility Name
Institut Català d'Oncologia
City
Badalona
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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SEL24/MEN1703 in Patients With Acute Myeloid Leukemia

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