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Food Effect Study of Alisertib (MLN8237) in Patients With Advanced Solid Tumors or Lymphomas

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ClinicalTrials.gov Identifier: NCT01898078
Recruitment Status : Unknown
Verified January 2017 by Takeda ( Millennium Pharmaceuticals, Inc. ).
Recruitment status was:  Active, not recruiting
First Posted : July 12, 2013
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief Summary:
This is an open-label, multicenter, phase 1 study with the primary objective of evaluating the effect of food on the single-dose PK properties of alisertib administered as the ECT formulation. The secondary objective is to further evaluate the safety and tolerability of alisertib.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Lymphoma Drug: MLN8237 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 1, Two-Way, Cross-Over Study of the Effect of the Food on the Pharmacokinetics of MLN8237 (Alisertib) in Patients With Advanced Solid Tumors or Lymphomas
Study Start Date : July 2013
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: MLN8237 Drug: MLN8237
Patients will be randomly assigned in a crossover fashion to receive a single 50-mg dose of alisertib (administered as 5 x 10 mg enteric-coated tablets) with or without a standard high-fat breakfast on Day 1 of Cycle 1, with the respective alternate food intake condition (fasted to fed, or fed to fasted; n = approximately 9 per sequence) on Day 1 in Cycle 2.
Other Name: alisertib




Primary Outcome Measures :
  1. Ratio of geometric mean maximum plasma concentration (Cmax) of alisertib with food versus without food and associated 90% confidence intervals (CI) [ Time Frame: Days 1 through 4 of Cycles 1 & 2 ]
  2. Ratio of geometric mean area under the plasma concentration versus time curve zero to the time of the last measurement (AUC0-last) of alisertib with food versus without food and associated 90% CI [ Time Frame: Days 1 through 4 of Cycles 1 & 2 ]
  3. Ratio of geometric mean area under the plasma concentration versus time curve zero to infinity (AUC0-inf) of alisertib with food versus without food and associated 90% CI [ Time Frame: Days 1 through 4 of Cycles 1 & 2 ]

Secondary Outcome Measures :
  1. Evaluation of safety and tolerability of alisertib following single and multiple doses. Safety and tolerability as assessed by evaluation of adverse events (AEs), changes in laboratory values, and vital signs. [ Time Frame: Recorded from first dose of study drug through 30 days after the last dose of study drug ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • 18 years or older
  • Histologically or cytologically confirmed advanced tumors or lymphomas for which standard curative or life-prolonging treatment does not exist, or is no longer effective or tolerable
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patient must meet protocol-specified laboratory values
  • Female patients who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time or agree to practice true abstinence
  • Male patients who agree to practice effective barrier contraception during the entire study and through 4 months after the last dose of study drug OR agree to practice true abstinence

Exclusion Criteria:

  • Prior or current investigational therapies within 4 weeks before the first dose of alisertib
  • Female patients who are lactating or pregnant
  • Patient requiring treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days before the first dose of alisertib and during the study
  • Medical conditions requiring daily, chronic, or regular use of proton pump inhibitors(PPIs) within 7 days preceding the first dose of alisertib, or H2-receptor antagonists
  • Patient requiring systemic anticoagulation
  • Ongoing nausea or vomiting that is Grade 2 or worse in intensity
  • Known GI disease or GI procedures that could interfere with the oral absorption, excretion, or tolerance of alisertib
  • History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease
  • Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
  • Patients who are lactose-intolerant or are unwilling/unable to consume the protocol specified standardized high-fat breakfast

Other protocol-defined inclusion/exclusion 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): NCT01898078


Locations
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United States, New York
Bronx, New York, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.

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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01898078     History of Changes
Other Study ID Numbers: C14017
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017

Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
MLN8237
alisertib
food effects

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