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SEL24 in Patients With AML

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ClinicalTrials.gov Identifier: NCT03008187
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
Theradex
Menarini Group
Information provided by (Responsible Party):
Selvita S.A.

Brief Summary:

Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of SEL24 in patients with AML.

At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2.

In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients who are unfit to receive intensive chemotherapy.


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: SEL24 Phase 1 Phase 2

Detailed Description:

This is a Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of SEL24 in patients with AML. At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2. In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients who are unfit to receive intensive chemotherapy.

Part 1 will commence with an accelerated dose escalation design for the first 4 cohorts. The study will then follow a 3+3 design from Cohort 5 onwards in order to provide adequate PK profile data. In Part 1 the MTD is defined as the highest dose at which no more than 1 in up to 6 patients experience a DLT during Cycle 1. The dose escalation rules to be followed during Part 1 of the study are described in the study protocol.

The highest SEL24 dose level considered to be well tolerated in 6 patients, and to have optimal PK and PD characteristics, will be called the RD and will be selected for further evaluation in Part 2.

Part 2 will enroll patients at the RD identified in Part 1. The treatment groups in Part 2 will be opened for recruitment based on recommendation by the Investigators, Medical Monitor and Sponsor.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
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 : January 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: SEL24

SEL24 will be taken orally once daily for 14 consecutive days over a 21-day treatment cycle. The cohort dose may be escalated by an increase in the daily dose level during the study based on the dose escalation rules.

Continuation of the study treatment may be discussed between the investigator and the Sponsor on a case by case basis. The DMC may also advise on the suitability of an individual patient to continue to receive study treatment.

Patients who experience a DLT will be permitted to receive further treatment with SEL24 according to the dose modification rules described in the study protocol.

Drug: SEL24

SEL24 taken orally once daily for 14 consecutive days over a 21-day treatment cycle.

Part 1 will commence with an accelerated dose escalation design. Part 2 will enroll patients at the recommended dose identified in Part 1.

Other Name: SEL24-B489




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of AML
  • no standard therapeutic options available (to be supplemented)

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)

Information from the National Library of Medicine

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


Contacts
Contact: Ireneusz Otulski, MD +48 608 507347 ireneusz.otulski@selvita.com
Contact: Laurie Ford Graham, RN, MSN 609-608-2152 lgraham@theradex.com

Locations
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Scott R Solomon, MD    404-255-1930    ssolomon@bmtga.com   
Contact: Stacey Brown    404-851-8238    stacey.brown@northside.com   
Principal Investigator: Scott R Solomon, MD         
United States, Ohio
Cleveland Clinic, Taussig Cancer Institute Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Aziz Nazha, MD    713-792-2121    nazhaa@ccf.org   
United States, Tennessee
Vanderbilt Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Stephen A Strickland Jr, MD, MSCI    615-936-8422    stephen.strickland@vanderbilt.edu   
Principal Investigator: Stephen A Strickland Jr, MD, MSCI         
Sub-Investigator: Michael R Savona, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Farhad Ravandi, MD    713-745-0394    fravandi@mdanderson.org   
Principal Investigator: Farhad Ravandi, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Roland B Walter, MD         
Contact    (206) 667-3599    rwalter@fredhutch.org   
Sponsors and Collaborators
Selvita S.A.
Theradex
Menarini Group
Investigators
Principal Investigator: Farhad Ravandi, MD Department of Leukemia, MDACC

Responsible Party: Selvita S.A.
ClinicalTrials.gov Identifier: NCT03008187     History of Changes
Other Study ID Numbers: CLI24-001
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Selvita S.A.:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms