A Study of Alisertib (MLN8237) in Adult East Asian Patients With Advanced Solid Tumors or Lymphomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01512758
First received: January 13, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

This is an open-label, multicenter, phase 1 study of alisertib in East Asian patients (eg, patients from countries including but not limited to Singapore, Hong Kong, Taiwan, and South Korea) with either relapsed or refractory advanced solid tumors or lymphomas for which no effective standard treatment is available.


Condition Intervention Phase
Advanced Solid Tumors
Lymphomas
Drug: Alisertib
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation and Pharmacokinetic Study of Alisertib (MLN8237), an Aurora A Kinase Inhibitor, in Adult East Asian Patients With Advanced Solid Tumors or Lymphomas

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of adverse events, serious adverse events, assessments of clinical laboratory values and clinically important abnormalities, and vital sign measurements [ Time Frame: From start of study to 30 days after the last dose of study drug; approximately 12 months ] [ Designated as safety issue: Yes ]
    Safety profile and maximum tolerated dose (MTD) of alisertib; and to determine the recommended phase 2 dose of alisertib

  • PK parameters, including, but not limited to Cmax, AUC0-t, steady-state apparent oral clearance (CLss/F), terminal half-life (t1/2), accumulation ratio (Rac) and peak-to-trough ratio (PTR) [ Time Frame: Cycle 1: Days 1,3,5,7,8,9,10,11, 13 and Cycle 2: Day 8 ] [ Designated as safety issue: No ]
    Pharmacokinetics of alisertib


Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: At completion of Cycle 2 and every 2 cycles for up to 12 months or until progressive disease ] [ Designated as safety issue: No ]
    Based on investigator's assessment using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (solid tumors) or modified 2007 International Working Group (IWG) criteria (lymphomas)

  • Duration of response [ Time Frame: First documented response until disease progression; approximately 12 months ] [ Designated as safety issue: No ]
    Based on investigator's assessment using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (solid tumors) or modified 2007 International Working Group (IWG) criteria (lymphomas)

  • Concentrations of relevant tumor markers [ Time Frame: Cycle 1, Day 1; at end of Cycle 2 and every 2 cycles thereafter; and at end treatment; approximately 12 months ] [ Designated as safety issue: No ]
    Measurement of tumor markers (eg PSA, CA-125) from blood sample, if applicable.


Enrollment: 36
Study Start Date: February 2012
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alisertib Drug: Alisertib
Alisertib will be given orally twice daily for 7 consecutive days followed by a 14-day rest period (cycle length = 21 days). If, at the end of 14 days of rest, all alisertib-related toxicities (except alopecia) have not resolved to less than Grade 2, the cycle will be extended to a maximum of 28 days (ie, additional 7-day rest period). Patients will continue to receive repeated cycles of alisertib treatment for as long as their disease has not progressed and they have not experienced unacceptable alisertib-related toxicity.
Other Name: MLN8237

  Eligibility

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

Inclusion Criteria:

  • Male or female East Asian patients 18 years or older
  • Histologically or cytologically confirmed metastatic and/or advanced solid tumors or lymphomas for which no effective standard treatment is available
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Expected survival longer than 3 months from study enrollment
  • Radiographically or clinically evaluable tumor
  • Female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse
  • Male patients who agree to practice effective barrier contraception through 6 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
  • Voluntary written consent

Exclusion Criteria:

  • Female patients who are lactating or pregnant
  • Treatment with any investigational products, systemic antineoplastic treatment, or antineoplastic treatment with glucocorticoids within 21 days preceding the first dose of alisertib
  • Treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment within 42 days (21 days if clear evidence of progressive disease)
  • Medical conditions requiring daily, chronic, or regular use of proton pump inhibitors or H2-receptor antagonists
  • Treatment with radioimmunoconjugates such as ibritumomab tiuxetan or tositumomab within 56 days preceding first alisertib dose
  • Major surgery within the 14 days preceding the first dose of alisertib
  • Life-threatening or uncontrolled medical illness unrelated to cancer
  • Known gastrointestinal (GI) disease or procedures that could interfere with the oral absorption or tolerance of alisertib
  • Inability to swallow capsules
  • Inadequate bone marrow or other organ function
  • Diagnosed or treated for another malignancy within 2 years of first dose of alisertib, or previously diagnosed with another malignancy and have any radiographic or biochemical marker evidence of active disease. In the case of prior prostate cancer treated with radiotherapy, the prostate specific antigen (PSA) may be detectable, but must be < 1 ng/mL. Patients with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy of any type are not excluded
  • Other severe acute or chronic medical or psychiatric conditions, including uncontrolled diabetes, or laboratory abnormality
  • Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
  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: NCT01512758

Locations
Singapore
National Cancer Centre
Tiong Bahru, Singapore, 169610
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: NCT01512758     History of Changes
Other Study ID Numbers: C14013
Study First Received: January 13, 2012
Last Updated: December 3, 2013
Health Authority: Singapore: Health Sciences Authority
Taiwan : Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Millennium Pharmaceuticals, Inc.:
East Asian Patients
Advanced solid tumors
Lymphomas
MLN8237
Alisertib
Aurora A Kinase Inhibitor

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

ClinicalTrials.gov processed this record on October 23, 2014