SEL24/MEN1703 in Patients With Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT03008187 |
Recruitment Status :
Active, not recruiting
First Posted : January 2, 2017
Last Update Posted : August 4, 2022
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Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia | Drug: SEL24/MEN1703 | Phase 1 Phase 2 |
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 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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
United States, Georgia | |
Northside Hospital | |
Atlanta, Georgia, United States, 30342 | |
United States, Ohio | |
Cleveland Clinic, Taussig Cancer Institute | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 | |
United States, Tennessee | |
Vanderbilt Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Texas Oncology - Baylor Charles A. Sammons Cancer Center | |
Dallas, Texas, United States, 75246 | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 | |
Italy | |
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | |
Meldola, Italy | |
Istituto Clinico Humanitas | |
Milano, Italy | |
ASST Monza - Ospedale San Gerardo | |
Monza, Italy | |
Poland | |
Institute of Haematology and Blood Transfusion | |
Warsaw, Poland | |
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii z Pododdzialem Chemioterapi | |
Łódź, Poland | |
Spain | |
Institut Català d'Oncologia | |
Badalona, Spain | |
Hospital 12 de Octubre | |
Madrid, Spain | |
Hospital Universitari i Politecnic La Fe | |
Valencia, Spain |
Principal Investigator: | Farhad Ravandi, MD | Department of Leukemia, MDACC |
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: | August 4, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
AML Relapsed/Refractory Acute Myeloid Leukemia IDH |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms |