Advanced Solid TumorsPhase 1NCT01898078

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

A Phase 1 study testing Alisertib in people with Advanced Solid Tumors and Lymphoma, run by Millennium Pharmaceuticals, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors, Lymphoma
What is being tested?: Alisertib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 3 sitesUnited States
Study dates: 16 Jul 2013to 24 Jan 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Nashville, Tennessee
Study site
San Antonio, Texas
Study site
The Bronx, New York

Other trials in United States

About this study

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

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.

Conditions: Advanced Solid Tumors, Lymphoma
Being tested: Alisertib
Keywords: MLN8237, Alisertib, Food effects
Medical subject headings: Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlisertibDrug
Also called MLN8237
Alisertib ECT

Study groups in NCT01898078
Study group	Role	What they receive
Alisertib 50 mg Fed + Fasted	Experimental	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. Receives: Drug: Alisertib
Alisertib 50 mg Fasted + Fed	Experimental	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. Receives: Drug: Alisertib

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax: Maximum Observed Plasma Concentration of Alisertib
Measured: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib
Measured: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib
Measured: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 201324 Jan 2017

First posted12 Jul 2013 (estimated)
Study start16 Jul 2013
Primary completion5 Mar 2014
Study completion24 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01898078
Sponsor's protocol ID: C14017
Status last verified: Mar 2019
First submitted: 1 Jul 2013
Last updated: 21 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01898078
Acronym / sponsor ID: C14017
Conditions: Advanced Solid Tumors, Lymphoma
Keywords: MLN8237, Alisertib, Food effects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 16 Jul 2013 (actual)
Primary completion: 5 Mar 2014 (actual)
Study completion: 24 Jan 2017 (actual)
First posted: 12 Jul 2013 (estimated)
Results: Posted 21 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Alisertib 50 mg Fed + Fasted	Experimental	Drug: AlisertibAlisertib 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.
Alisertib 50 mg Fasted + Fed	Experimental	Drug: AlisertibAlisertib 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlisertibAlso: MLN8237Alisertib ECT	Drug	Alisertib 50 mg Fasted + Fed, Alisertib 50 mg Fed + Fasted

Primary outcome

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
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
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

3 secondary outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose through 30 days after the last dose of study drug (up to 225 days)
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Time frame: From first dose through 30 days after the last dose of study drug (up to 225 days)
Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs
Time frame: From first dose through 30 days after the last dose of study drug (up to 225 days)

Results and safety

Results posted to the registry on 21 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alisertib 50 mg Fed + Fasted	13	7
Alisertib 50 mg Fasted + Fed	13	5

Primary outcome: 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. Mean (Standard Deviation). Unit: nM

Measure	Alisertib 50 mg Fed n = 22	Alisertib 50 mg Fasted n = 22
Value	1338.6 (487.25)	1354.5 (432.17)

Alisertib 50 mg Fed vs Alisertib 50 mg Fasted: Least Squares Mean Ratio: 0.97 (90% CI 0.85 to 1.12)

Population analysed: Pharmacokinetic (PK) population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters.

Primary outcome: 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. Mean (Standard Deviation). Unit: hr*nM

Measure	Alisertib 50 mg Fed n = 22	Alisertib 50 mg Fasted n = 22
Value	24645.5 (12467.39)	20797.7 (8847.69)

Alisertib 50 mg Fed vs Alisertib 50 mg Fasted: Least Square Mean Ratio: 1.16 (90% CI 1.01 to 1.34)

Population analysed: PK population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters.

Primary outcome: 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. Mean (Standard Deviation). Unit: hr*nM

Measure	Alisertib 50 mg Fed n = 16	Alisertib 50 mg Fasted n = 14
Value	24537.5 (9882.10)	22771.4 (10206.21)

Alisertib 50 mg Fed vs Alisertib 50 mg Fasted: Least Square Mean Ratio: 1.15 (90% CI 0.96 to 1.39)

Population analysed: PK population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters. Here, number of participants analysed are the participants who were evaluable for this outcome measure.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose through 30 days after the last dose of study drug (up to 225 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alisertib 50 mg Fed + Fasted	7 of 13 (53.8%)	13 of 13 (100%)	0 of 13
Alisertib 50 mg Fasted + Fed	7 of 13 (53.8%)	13 of 13 (100%)	1 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Advanced Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Millennium Pharmaceuticals, Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Alisertib in people with Advanced Solid Tumors and Lymphoma, run by Millennium Pharmaceuticals, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01898078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.