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

NCT00807495 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: C14004U1111-1187-1268
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the anti-tumor activity of alisertib (MLN8237) in participants with relapsed or refractory non-hodgkin's lymphoma.

Conditions

Diffuse Large B-cell Lymphoma; Mantle Cell Lymphoma; Burkitt's Lymphoma; T-cell Lymphoma, Excluding Primary Cutaneous T-cell Lymphoma; Transformed Follicular Lymphoma With ≥ 50% Diffuse Large Cell Component

Keywords

MLN8237; Alisertib; Drug therapy

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria)

  Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria).

  Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years)

Secondary Outcomes (6)

• Time to Progression (TTP)

  Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)

• Progression Free Survival (PFS)

  Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)

• Duration of Response (DOR)

  Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)

• Number of Participants With Treatment-Emergent Adverse Events

  First dose of study drug to 30 days after last dose (Up to 25 months)

• Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events

  First dose of study drug to 30 days after last dose (Up to 25 months)

Study Arms (1)

Alisertib 50 mg

EXPERIMENTAL

Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months or longer with Sponsor approval).

Drug: Alisertib

Interventions

Alisertib DRUG

Alisertib capsules

Also known as: MLN8237

Alisertib 50 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant 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.
• Male or female participants 18 years or older.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Measurable disease.

You may not qualify if:

• Pregnant or lactating females.
• Known human immunodeficiency virus (HIV) positive or AIDS-related illness.
• Any serious medical or psychiatric illness that could interfere with the completion of treatment.
• Total bilirubin ≥ 1.5 × the upper limit of normal (ULN).
• 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.
• Absolute neutrophil count (ANC) \< 1,250/mm\^3.
• Platelet count \< 75,000/mm\^3.
• Calculated creatinine clearance \< 30 mL/minute.
• Autologous stem cell transplant less than 6 months prior to enrollment.
• Participants who have undergone allogeneic stem cell or organ transplantation.
• Systemic antineoplastic therapy including glucocorticoids (\> 15 mg prednisone/day or equivalent), or treatment with an investigational agent within 14 days preceding the first dose of study drug treatment.
• Participants who have received treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment, within 12 weeks prior to first dose.
• Participants who have received treatment with radioimmunoconjugates or within 12 weeks prior to first dose.
• Participants who have received radiotherapy within 21 days prior to first dose.
• 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.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (1)

Hematology Oncology Associates, Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Related Publications (1)

• Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

  PMID: 17242396 RESULT

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell; Burkitt Lymphoma; Lymphoma, T-Cell

Interventions

MLN 8237

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 12, 2008
• Study Start: February 10, 2009
• Primary Completion: January 4, 2011
• Study Completion: February 13, 2013
• Last Updated: March 27, 2018
• Results First Posted: March 27, 2018

Record last verified: 2018-02

Locations

US (1)