Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00807495
First received: December 11, 2008
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

This is an open-label, multicenter, phase 2 study of alisertib a/k/a MLN8237 in patients with relapsed or refractory non-hodgkin's lymphoma.


Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Mantle Cell Lymphoma
Burkitt's Lymphoma
Precursor B-lymphoblastic Leukemia/Lymphoma
T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma
Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component
Drug: MLN8237
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Response rate: partial plus complete [ Time Frame: CT scans of neck, chest, abdomen, pelvis, and PET scan are performed during screening and repeated, up to 12 months. Bone marrow aspiration and biopsy are performed during screening and to confirm CR if appropriate. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression, progression free survival, and duration of response. [ Time Frame: Imaging performed serially to 12 months. Bone marrow performed during screening and repeated to confirm complete response if appropriate. ] [ Designated as safety issue: No ]
  • Safety, tolerability based on vital signs, physical examination, laboratory tests, adverse events [ Time Frame: Through 30 days after last dose. ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: February 2009
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MLN8237
Drug: MLN8237
MLN8237 will be administered orally at a dose of 50 mg twice daily for seven consecutive days followed by a 14-day rest period, in 21-day cycles until there is evidence of disease progression or unacceptable treatment-related toxicity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  1. Patients must have histological or cytological diagnosis of a hematological malignancy of the following types that has relapsed or was refractory to prior therapy:

    • Diffuse large B-cell lymphoma
    • Mantle cell lymphoma
    • Burkitt's lymphoma
    • Precursor B-lymphoblastic leukemia/lymphoma
    • T-cell lymphoma, excluding primary cutaneous T-cell lymphoma
    • Transformed follicular lymphoma with ≥ 50% diffuse large cell component
  2. Male or female patients 18 years or older
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  4. Measurable disease

Exclusion criteria include the following:

  1. Pregnant or lactating females
  2. Known human immunodeficiency virus (HIV) positive or AIDS-related illness
  3. Any serious medical or psychiatric illness that could interfere with the completion of treatment
  4. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN)
  5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5 × the ULN. AST, ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to their underlying hematological disorder.
  6. Absolute neutrophil count (ANC) < 1,250/mm3
  7. Platelet count < 75,000/mm3
  8. Calculated creatinine clearance < 30 mL/minute
  9. Autologous stem cell transplant less than 6 months prior to enrollment
  10. Patients who have undergone allogeneic stem cell or organ transplantation
  11. Systemic antineoplastic therapy within 14 days preceding the first dose of study drug treatment
  12. Patients who have received treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment, within 42 days
  13. Patients who have received treatment with radioimmunoconjugates or within 12 weeks
  14. Patients who have received radiotherapy within 21 days prior to first dose
  15. Myocardial infarction within 6 months of enrollment or current history of New York Heart Association(NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
  16. Major surgery within 14 days prior to the first dose
  17. Infection requiring systemic antibiotic therapy within 14 days prior to the first dose or other serious infection
  18. Clinically uncontrolled central nervous system (CNS) involvement.
  19. Inability to swallow capsules
  20. History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807495

Locations
United States, New Jersey
Hematology Oncology Associates, Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00807495     History of Changes
Other Study ID Numbers: C14004
Study First Received: December 11, 2008
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:
MLN8237
alisertib

Additional relevant MeSH terms:
Burkitt Lymphoma
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, Mantle-Cell
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014