SEL24/MEN1703 in Patients With Acute Myeloid Leukemia

Sponsor

Menarini Group (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03008187

Collaborator

Medpace, Inc. (Industry), Theradex (Industry)

Enrollment

Locations

Arm

65.7

Anticipated Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

Anticipated 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 :

Mar 10, 2017

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

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

Primary Outcome Measures

Dose limiting toxicity (DLT) evaluation [DLTs in patients during their first 21-day treatment cycle]
Maximum tolerated dose (MTD) or maximum administered dose (MAD) estimate

Secondary Outcome Measures

Safety profile of single agent SEL24/MEN1703 [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northside Hospital	Atlanta	Georgia	United States	30342
2	Cleveland Clinic, Taussig Cancer Institute	Cleveland	Ohio	United States	44195
3	Oregon Health and Science University	Portland	Oregon	United States	97239
4	Vanderbilt Ingram Cancer Center	Nashville	Tennessee	United States	37232
5	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas	United States	75246
6	MD Anderson Cancer Center	Houston	Texas	United States	77030
7	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
8	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola		Italy
9	Istituto Clinico Humanitas	Milano		Italy
10	ASST Monza - Ospedale San Gerardo	Monza		Italy
11	Institute of Haematology and Blood Transfusion	Warsaw		Poland
12	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii z Pododdzialem Chemioterapi	Łódź		Poland
13	Institut Català d'Oncologia	Badalona		Spain
14	Hospital 12 de Octubre	Madrid		Spain
15	Hospital Universitari i Politecnic La Fe	Valencia		Spain