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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

December 11, 2008
November 15, 2013
February 2009
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00807495 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma
A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Aggressive Non-Hodgkin's Lymphoma

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
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
Experimental: 1
MLN8237
Intervention: Drug: MLN8237
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00807495
C14004
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP