SEL24/MEN1703 in Patients With Acute Myeloid Leukemia



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:January 2017
End Date:May 2020
Contact:Simone Baldini, MD
Email:SBaldini@menarini-ricerche.it
Phone:+39 345 922 0957

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A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia

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.

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
every 14 days over 21-day cycle.

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)
We found this trial at
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Cleveland, Ohio 44195
Phone: 713-792-2121
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Stephen A Strickland Jr, MD, MSCI
Phone: 615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Seattle, WA
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Scott R Solomon, MD
Phone: 404-255-1930
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, GA
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Houston, Texas 77030
Principal Investigator: Farhad Ravandi, MD
Phone: 713-745-0394
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Houston, TX
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