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Study of ME-401 in Subjects With Relapsed/Refractory CLL/SLL or FL
This study is currently recruiting participants.
Verified September 2016 by MEI Pharma, Inc.
Sponsor:
MEI Pharma, Inc.
Collaborator:
Clinipace LTD
Information provided by (Responsible Party):
MEI Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT02914938
First received: September 12, 2016
Last updated: August 14, 2017
Last verified: September 2016
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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:
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
Follicular Lymphoma
U.S. FDA Resources
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| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02914938
Please refer to this study by its ClinicalTrials.gov identifier: 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 | Not yet 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 | Not yet 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 |
| Study First Received: | September 12, 2016 |
| Last Updated: | August 14, 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 |
ClinicalTrials.gov processed this record on August 22, 2017