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CompletedNCT01898078Updated Jun 21, 2019Results posted

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

A Phase 1 interventional study of Alisertib in Advanced Solid Tumors and Lymphoma, sponsored by Millennium Pharmaceuticals, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-21.

Sponsored by Millennium Pharmaceuticals, Inc. (part of Takeda) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of food on the single-dose pharmacokinetics (PK) of alisertib administered as an enteric-coated tablet (ECT) formulation in participants with advanced solid tumors or lymphomas.

Read the detailed description

The drug being tested in this study is called alisertib. Alisertib is being tested in adult participants with advanced solid tumors or lymphomas.

The study enrolled 26 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • Alisertib 50 mg Fed + Fasted
  • Alisertib 50 mg Fasted + Fed

All participants will be asked to take one alisertib tablet (ECT), orally, with or without a standard high-fat breakfast Cycle 1, Day 1, with the respective alternate food intake condition (fasted to fed or fed to fasted) on Cycle 2, Day 1, each followed by 14-day rest period. Participants will take alisertib, ECT, orally BID on Days 4 to 10 of Cycles 1 and 2, each followed by 14-day rest period. From Cycle 3 onwards participants will continue taking alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in 21-day cycles until disease progression, occurrence of an unacceptable alisertib-related toxicity.

This multi-center trial conducted at 3 sites in the United States. Participants will make multiple visits to the clinic and plus a final visit after 30 days of receiving their last dose of drug for a follow-up assessment.

02

Conditions studied

  • Advanced Solid Tumors
  • Lymphoma

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Keywords

  • MLN8237
  • Alisertib
  • Food effects
03

In context

Lymphoma

5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.

This study's enrollment of 26 is below the median of 40 across 4,534 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Millennium Pharmaceuticals, Inc. is the lead sponsor of 178 studies on the registry; none are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 73 (99%) have results posted.

First submitted after Millennium Pharmaceuticals, Inc. became part of Takeda.

Browse Millennium Pharmaceuticals, Inc. studies →All Takeda studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Participant must meet protocol-specified laboratory values
  • Suitable venous access
  • Female participants 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 participants 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

Exclusion Criteria:

  • Prior or current investigational therapies within 4 weeks before the first dose of alisertib
  • Female participants who are lactating or pregnant
  • Participant 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 histamine (H2)-receptor antagonists
  • Participant requiring systemic anticoagulation
  • Ongoing nausea or vomiting that is Grade 2 or worse in intensity
  • Known gastrointestinal (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
  • Participant 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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Alisertib 50 mg Fed + Fasted

    Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.

    Drug: Alisertib

  • Experimental
    Alisertib 50 mg Fasted + Fed

    Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.

    Drug: Alisertib

Interventions

  • DrugAlisertib

    Alisertib ECT

    Also known as: MLN8237

06

What researchers measure

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration of Alisertib

    Time frame: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

  2. AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib

    Time frame: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

  3. AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib

    Time frame: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

    Time frame: From first dose through 30 days after the last dose of study drug (up to 225 days)

  2. Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs

    The number of participants with any clinical significant change in safety laboratory values collected throughout the study.

    Time frame: From first dose through 30 days after the last dose of study drug (up to 225 days)

  3. Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs

    The number of participants with any clinical significant change in vital signs (sitting diastolic and systolic blood pressure, heart rate, and temperature) were collected throughout the study.

    Time frame: From first dose through 30 days after the last dose of study drug (up to 225 days)

07

Results

Posted Jun 21, 2019

Participant flow

Participants took part in the study at 3 investigative sites in the United States from 16 July 2013 to 24 January 2017. Data cut-off for the primary analysis was 05 March 2014.

Participant flow — Overall Study
MilestoneAlisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + Fed
Started1313
Completed75
Not completed68
Withdrew: Progressive disease15
Withdrew: Adverse event21
Withdrew: Withdrawal by subject11
Withdrew: Symptomatic deterioration20
Withdrew: Reason not specified01

Outcome measures

PrimaryCmax: Maximum Observed Plasma Concentration of Alisertib
Time frame:
Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Reported as:
Mean · nM
Cmax: Maximum Observed Plasma Concentration of Alisertib
nMAlisertib 50 mg FedAlisertib 50 mg Fasted
Cmax: Maximum Observed Plasma Concentration of Alisertib1338.6 ± 487.251354.5 ± 432.17
Statistical analysis
  • Alisertib 50 mg Fed vs Alisertib 50 mg Fasted · Least squares mean ratio: 0.97 · 90% CI 0.85 to 1.12Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.
PrimaryAUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib
Time frame:
Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Reported as:
Mean · hr*nM
AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib
hr*nMAlisertib 50 mg FedAlisertib 50 mg Fasted
AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib24645.5 ± 12467.3920797.7 ± 8847.69
Statistical analysis
  • Alisertib 50 mg Fed vs Alisertib 50 mg Fasted · Least square mean ratio: 1.16 · 90% CI 1.01 to 1.34Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.
PrimaryAUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib
Time frame:
Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Reported as:
Mean · hr*nM
AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib
hr*nMAlisertib 50 mg FedAlisertib 50 mg Fasted
AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib24537.5 ± 9882.1022771.4 ± 10206.21
Statistical analysis
  • Alisertib 50 mg Fed vs Alisertib 50 mg Fasted · Least square mean ratio: 1.15 · 90% CI 0.96 to 1.39Estimates for each PK parameter were obtained using a mixed effects model of log(PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.
SecondaryNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Time frame:
From first dose through 30 days after the last dose of study drug (up to 225 days)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
ParticipantsAlisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + Fed
AEs1313
SAEs77
SecondaryNumber of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs

The number of participants with any clinical significant change in safety laboratory values collected throughout the study.

Time frame:
From first dose through 30 days after the last dose of study drug (up to 225 days)
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
ParticipantsAlisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + Fed
Neutropenia108
Anaemia53
Leukopenia52
Thrombocytopenia12
Hypokalaemia03
Hyperbilirubinaemia11
Neutrophil count decreased11
Lymphopenia01
Hyperkalaemia10
Hypomagnesaemia01
Aspartate aminotransferase increased01
Blood bilirubin increased10
SecondaryNumber of Participants With Clinically Significant Change in Vital Sign Reported as AEs

The number of participants with any clinical significant change in vital signs (sitting diastolic and systolic blood pressure, heart rate, and temperature) were collected throughout the study.

Time frame:
From first dose through 30 days after the last dose of study drug (up to 225 days)
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs
ParticipantsAlisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + Fed
Hypertension01
Hypotension01
Tachycardia01

Adverse events

Collected over From first dose through 30 days after the last dose of study drug (up to 225 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alisertib 50 mg Fed + Fasted0/13 (0%)7/13 (53.8%)13/13 (100%)
Alisertib 50 mg Fasted + Fed1/13 (7.7%)7/13 (53.8%)13/13 (100%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventAlisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + Fed
Abdominal painGastrointestinal disorders2/131/13
Rectal haemorrhageGastrointestinal disorders0/131/13
CellulitisInfections and infestations0/131/13
BacteraemiaInfections and infestations1/130/13
Pneumonia streptococcalInfections and infestations1/130/13
PyelonephritisInfections and infestations0/131/13
HaemoptysisRespiratory, thoracic and mediastinal disorders1/130/13
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/131/13
Muscular weaknessMusculoskeletal and connective tissue disorders0/131/13
DeliriumPsychiatric disorders0/131/13
Most frequent other events
Showing 10 of 133
Most frequent other events
EventAlisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + Fed
NeutropeniaBlood and lymphatic system disorders11/138/13
FatigueGeneral disorders8/133/13
StomatitisGastrointestinal disorders3/138/13
AlopeciaSkin and subcutaneous tissue disorders8/137/13
VomitingGastrointestinal disorders3/137/13
AnaemiaBlood and lymphatic system disorders6/134/13
LeukopeniaBlood and lymphatic system disorders5/133/13
PyrexiaGeneral disorders1/135/13
DiarrhoeaGastrointestinal disorders5/134/13
NauseaGastrointestinal disorders2/135/13

Baseline characteristics

Safety population included all enrolled participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)Alisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + FedTotal
Mean59.6 ± 10.1561.7 ± 12.6460.7 ± 11.28
Sex: Female, Male
Sex: Female, Male(Participants)Alisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + FedTotal
Female6713
Male7613
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Alisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + FedTotal
Hispanic or Latino549
Not Hispanic or Latino8917
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Alisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + FedTotal
White101323
Black or African American303
Region of Enrollment
Region of Enrollment(Participants)Alisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + FedTotal
United States131326
Height
Height(cm)Alisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + FedTotal
Mean166.9 ± 14.34165.3 ± 11.32166.1 ± 12.68
Weight
Weight(kg)Alisertib 50 mg Fed + FastedAlisertib 50 mg Fasted + FedTotal
Mean73.59 ± 15.48478.37 ± 20.18375.98 ± 17.792
08

Study locations

3 sites
  • The Bronx, New York, United States
  • Nashville, Tennessee, United States
  • San Antonio, Texas, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01898078
Lead sponsor
Millennium Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jul 12, 2013
Start date
Jul 16, 2013
Primary completion
Mar 5, 2014
Completion
Jan 24, 2017
Results posted
Jun 21, 2019
Last update
Jun 21, 2019

Study contacts

Medical Monitor
study director · Millennium Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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