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A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma (LAM-002A/NHL)

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ClinicalTrials.gov Identifier: NCT02594384
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : June 16, 2017
Information provided by (Responsible Party):
Lam Therapeutics Inc.

Brief Summary:
This is a Phase 1 dose exploration study of LAM-002A administered by mouth in patients with relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK) and preliminary activity will be evaluated.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: LAM-002A Phase 1

Detailed Description:

LAM-002A is supplied as 25 mg capsules and will be administered twice daily (BID) by mouth with a cycle length of 28 days. Patients will be advised to take the doses at the same time each day, approximately 12 hours apart on an empty stomach (no food within 2 hours prior to dose, or within 2 hours after dose).

A 3 + 3 design will be utilized to define a maximum tolerated dose (MTD). The MTD is defined as the highest dose at which no more than 1 of 6 patients (i.e., < 33%) experiences a dose-limiting toxicity (DLT) in the dose cohort.

Once the dose and schedule are established, additional patients will be treated to better characterize the safety, tolerability, preliminary anti-tumor activity, PK and pharmacodynamics of the study drug.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A (Apilimod Dimeyslate Capsules) Administered Orally in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
Study Start Date : October 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single, open label
Single arm, open label. All patients will receive LAM-002A twice daily by mouth until progression or intolerability. Cycles will be 28 days long.
Drug: LAM-002A
25 mg capsules
Other Name: apilimod dimesylate

Primary Outcome Measures :
  1. Determination of the MTD of oral LAM-002A [ Time Frame: 28 days ]
    Dose escalation until determination of dose limiting toxicities

Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of LAM-002A [ Time Frame: 28 days ]
    Evaluation of LAM-002A and its metabolites in plasma

  2. Area under the plasma concentration versus time curve (AUC) of LAM-002A [ Time Frame: 28 days ]
    Evaluation of LAM-002A and its metabolites in plasma

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 cycle (28 days) to 6 or more cycles ]
    Identify toxicities

  4. Evaluate primary anti-tumor activity [ Time Frame: 1 cycle (28 days) to 6 or more cycles ]
    evaluate the ability of LAM-002A to shrink tumors

Other Outcome Measures:
  1. Microscopic changes in the internal structure of tumor cells and white blood cells [ Time Frame: 1 cycle (28 days) to 2 cycles ]
    Determine the effect of LAM-002A on tumor cells and blood samples

  2. Evaluation of genetic alterations and expressions in tumor [ Time Frame: 1 cycle (28 Days) to 2 cycles ]
    Determine potential genetic make-up of NHL tumors

  3. Evaluation of immune modulatory effects of LAM-002A [ Time Frame: 1 cycle (28 days) to 2 cycles ]
    Determine immune modulation activity of LAM-002A

  4. Plasma identification of analytes [ Time Frame: 1 cycle (28 days) ]
    Preliminary assessment of anti-lymphoma activity

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Able to understand and comply with the protocol requirements and has signed the informed consent document.
  2. Confirmed diagnosis of B-cell Non-Hodgkin's lymphoma limited to follicular lymphoma (FL), DLBCL, mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) or CLL/SLL that has progressed and for which standard curative measures do not exist or are no longer effective. Prior therapy must have included a rituximab-based regimen.
  3. Patients with DLBCL must have progressed after transplant, or be unwilling, unable or not an appropriate candidate for an autologous stem cell transplant
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.
  5. Adequate organ and marrow function.
  6. Able to swallow oral capsules without difficulty.

9. Acceptable birth control. 10. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test at screening.

Exclusion Criteria:

  1. Patients with central nervous system (CNS) lymphoma are not eligible for the trial unless the disease had been treated and the subject remains without symptoms with no active CNS lymphoma.
  2. Not recovered from toxicity due to all prior therapies.
  3. Other uncontrolled significant illness .
  4. History of malabsorption or other gastrointestinal (GI) disease that may significantly alter the absorption of apilimod
  5. The patient has undergone major surgery within 28 days prior to first dose of study drug.
  6. Past history of tuberculosis (TB) or active infection with TB, human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
  7. The patient is lactating and breast feeding.
  8. Unable or unwilling to abide by the study protocol or cooperate fully with the Investigator or designee.

This is a shortened list and additional criteria may apply.

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): NCT02594384

Contact: Henri Lichenstein, PhD 2034587100 ext 318 hlichens@lamthera.com

United States, Alabama
Clearview Cancer Institute Recruiting
Huntsville, Alabama, United States, 35805
Contact: Avitra Bone, RN    256-705-4283    studycoordinator@ccihsv.com   
Principal Investigator: Marshall Schreeder, MD         
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Lisa Melfi    904-953-3320    melfi.lisa@mayo.edu   
Principal Investigator: Taimur Sher, MD         
United States, Georgia
Winship Cancer Institute at Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kaylan Dixon    404-778-4449    kaylan.dixon@emory.edu   
Principal Investigator: Jonathan Cohen, MD         
United States, Indiana
Horizon Oncology Research, Inc. Recruiting
Lafayette, Indiana, United States, 47905
Contact: Wael A Harb, MD    765-446-5111    wharb@horizonbioadvance.com   
Principal Investigator: Wael A Harb, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Curtis Wong    617-643-3621    cwong17@mgh.harvard.edu   
Principal Investigator: Jeremy Abramson, MD         
United States, Michigan
Cancer and Hematology Centers of Western Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Yvette Cole, RN, BSN, OCN    616-954-5554    yvette.cole@startmidwest.com   
Principal Investigator: Nehal Lakhani, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Corinne Parker    507-266-3784    parker.corinne@mayo.edu   
Principal Investigator: Stephen Ansell, MD         
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Ion Marinescu    646-501-7920    Ion.Marinescu@nyumc.org   
Principal Investigator: Catherine Diefenbach, MD         
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Rita Gazivoda    212-746-0702    rig9021@med.cornell.edu   
Principal Investigator: Sarah Rutherford, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Anas Najjar    206-287-5671    Anas.Najjar@virginiamason.org   
Principal Investigator: David Aboulafia, MD         
Sponsors and Collaborators
Lam Therapeutics Inc.
Principal Investigator: Jeremy Abramson, MD Massachusetts General Hospital

Responsible Party: Lam Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02594384     History of Changes
Other Study ID Numbers: LAM-002A-NHL-CLN01
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: August 2016

Keywords provided by Lam Therapeutics Inc.:
Phase 1
Apilimod dimesylate
Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases