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Study of ME-401 in Subjects With Relapsed/Refractory CLL/SLL or FL

This study is currently recruiting participants.
Verified November 2017 by MEI Pharma, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02914938
First Posted: September 26, 2016
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Clinipace LTD
Information provided by (Responsible Party):
MEI Pharma, Inc.
  Purpose
The purpose of this study is to determine the minimum biologically effective dose of ME-401; determine the maximally tolerated dose of ME-401 and determine the dose limiting toxicities of ME-401. Secondary objectives to evaluate the safety profile and efficacy of ME-401.

Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma Follicular Lymphoma Drug: ME-401 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-Label, Dose Escalation Study of ME-401 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Follicular Lymphoma (FL)

Resource links provided by NLM:


Further study details as provided by MEI Pharma, Inc.:

Primary Outcome Measures:
  • Minimum Biologically Effective Dose (mBED) of ME-401 [ Time Frame: 1 year ]
    The mBED will be defined as the dose that is safe and that achieves an objective response rate

  • Maximally Tolerated Dose (MTD) of ME-401 [ Time Frame: 1 year ]
    The MTD will be determined as the dose level with a DLT rate closest to .25

  • Dose Limiting Toxicities (DLTs) of ME-401 [ Time Frame: within the first 56 days ]
    DLTs will be measured by the number of AEs that occur within the first 56 days of ME-401 administration, is considered clinically significant by the P.I. and occurs in the presence of supportive care


Secondary Outcome Measures:
  • Safety profile of ME-401 [ Time Frame: 1 year ]
    Safety profile will be measured by number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  • The Recommended Phase 2 Dose (RP2D) [ Time Frame: 2 year ]
    The RP2D will be determined by the evaluation of safety and efficacy data

  • Peak Plasma Concentration (Cmax) [ Time Frame: 2 years ]
  • AUC (area under the concentration time curve) [ Time Frame: 2 years ]
  • Efficacy of ME-401 [ Time Frame: 2 years ]
    The efficacy of ME-401 assessed by the overall response (OR)

  • Efficacy of ME-401 [ Time Frame: 2 years ]
    Efficacy of ME-401 assessed by complete response (CR)

  • Efficacy of ME-401 [ Time Frame: 2 years ]
    Efficacy of ME-401 assessed by minimal residual disease negativity (MRD)

  • Efficacy of ME-401 [ Time Frame: 2 years ]
    Efficacy of ME-401 assessed by progression-free survival (PFS)


Estimated Enrollment: 84
Study Start Date: October 2016
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ME-401 Drug: ME-401

Detailed Description:

This is a Phase 1b, open-label, dose escalation/expansion study with seven planned dose levels (Cohorts) of ME-401. DLT will be assessed within the first 56 days (8 weeks). A Continual Reassessment Method (CRM) model will be used to determine dose escalation/de-escalation.

Dose levels will consist of 6 subjects and can be expanded to enroll up to 12 subjects. The total number of cohorts depends on the incidence of DLTs.

  Eligibility

Information from the National Library of Medicine

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of relapsed/refractory CLL and/or relapsed/refractory SLL or FL
  • No prior therapy with PI3Kd inhibitors
  • No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy
  • QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (ms)
  • For females of childbearing potential, a negative serum pregnancy test within 14 days of study Day 0

Exclusion Criteria:

  • Known histological transformation from CLL to an aggressive lymphoma
  • Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
  • Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody
  • Positive for hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody
  • Ongoing drug-induced pneumonitis
  • History of clinically significant cardiovascular abnormalities
  Contacts and Locations
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): NCT02914938


Contacts
Contact: Lisa McColley 402-238-2615 lmccolley@clinipace.com
Contact: Todd Butler (MEI) 858-369-7129 tbutler@meipharma.com

Locations
United States, California
Compassionate Care Recruiting
Corona, California, United States, 92708
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Stony Brook Recruiting
Stony Brook, New York, United States, 11794
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
St. Luke's Recruiting
Bethlehem, Pennsylvania, United States, 18015
United States, Tennessee
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37240
United States, Washington
Swedish Cancer Center Recruiting
Seattle, Washington, United States, 98104
United States, Wisconsin
Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Switzerland
lstituto Oncologico della Svizzera ltaliana Ospedale Regionale Bellinzona e Valli CH Recruiting
Bellinzona, Switzerland
Sponsors and Collaborators
MEI Pharma, Inc.
Clinipace LTD
Investigators
Study Director: Richard Ghalie (MEI Pharma, Inc.), MD Senior Vice President, Clinical Development
Study Chair: Andrew D Zelenetz, M.D. Ph.D Vice Chair, Medical Informatics Memorial Sloan Kettering
  More Information

Responsible Party: MEI Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02914938     History of Changes
Other Study ID Numbers: ME-401-002
First Submitted: September 12, 2016
First Posted: September 26, 2016
Last Update Posted: November 7, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Lymphoma
Leukemia
Lymphoma, Follicular
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, B-Cell