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CompletedNCT01844583Updated Mar 25, 2019Results posted

Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib

A Phase 1 interventional study of Alisertib and Esomeprazole in Solid Tumors and Lymphoma, sponsored by Millennium Pharmaceuticals, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-25.

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

Phase
Phase 1
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the drug-drug interaction (DDI) of either esomeprazole or rifampin on the single-dose PK of alisertib, and to complete an intensive QT study of single and multiple-dose alisertib.

Read the detailed description

The drug tested in this study is called alisertib. Alisertib is being tested to assess the effect of a proton pump inhibitor and strong metabolic inducer on the PK of a single 50 mg dose of alisertib administered as enteric-coated tablets (ECTs).

The study enrolled 55 patients. Participants received either:

  • Esomeprazole 40 mg and Alisertib 50 mg
  • Rifampin 600 mg and Alisertib 50 mg

All participants were asked to take one tablet of alisertib either once or twice daily in all cycles. In Cycle 2, participants were asked to take alisertib plus either esomeprazole or rifampin.

This trial was conducted the United States. The overall time to participate in this study was 10 months. Participants made multiple visits to the clinic plus a final visit, 30 days after receiving their last dose of study drug for a follow-up assessment.

02

Conditions studied

  • Solid Tumors
  • Lymphoma

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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 55 is above 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

  • Male or female participants 18 years or older
  • Histologically or cytologically confirmed metastatic and/or advanced solid tumors or lymphomas
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Expected survival longer than 3 months from enrollment in the study
  • Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse
  • Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse

Exclusion criteria

Exclusion Criteria:

  • Treatment with any anticancer therapy or any investigational agents within 4 weeks before the first dose of alisertib

    - Known hypersensitivity or intolerance to rifampin (for participants considered for the rifampin drug-drug interaction [DDI] group) or to esomeprazole (for participants considered for the esomeprazole DDI group)

  • Recurrent nausea and/or vomiting within 14 days before the first dose of alisertib, and known gastrointestinal (GI) abnormality or GI procedure that could interfere with or modify the oral absorption or tolerance of alisertib
  • Participants requiring treatment with clinically significant enzyme inducers within 14 days before the first dose of alisertib and/or requiring the use of these medications during the study
  • A medical condition requiring use of pancreatic enzymes; or daily, chronic, or regular use of proton pump inhibitors (PPI); or histamine (H2) receptor antagonists
  • Participants requiring systemic anticoagulation (excluding low-dose aspirin, or low-dose anticoagulation to maintain patency of venous access devices).
  • Any cardiovascular condition
  • Female participants who are lactating or have a positive serum pregnancy test

  • Major surgery within the 14 days preceding the first dose of alisertib

    - Life-threatening or uncontrolled medical illness unrelated to cancer

  • Newly diagnosed or uncontrolled cancer-related central nervous system (CNS) disease
  • Autologous stem cell transplant within 3 months

  • Prior allogeneic bone marrow or other organ transplantation

    - Other severe acute or chronic medical or psychiatric condition

  • Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection

Please note there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Esomeprazole 40 mg + Alisertib 50 mg

    Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1. Esomeprazole, 40 mg, delayed-release capsules, orally, once daily on Days 1 to 10 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2. Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles).

    Drug: Alisertib · Drug: Esomeprazole

  • Experimental
    Rifampin 600 mg + Alisertib 50 mg

    Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1. Rifampin 600 mg, capsules, orally, once daily on Days 1 to 10 in Cycle 2 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2. Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles).

    Drug: Alisertib · Drug: Rifampin

Interventions

06

What researchers measure

Primary outcomes

  1. Cmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Esomeprazole

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm

  2. AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Esomeprazole

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm

  3. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence and Absence of Esomeprazole

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm

  4. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Esomeprazole

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm

  5. Terminal Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Esomeprazole

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm

  6. Cmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Rifampin

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm

  7. AUC(Last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Rifampin

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm

  8. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence or Absence of Rifampin

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm

  9. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Rifampin

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm

  10. Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Rifampin

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm

  11. Change From the Time-matched Baseline in the Individually Corrected QTc Interval (QTcI)

    Time frame: Baseline, Days 1 and 10 multiple timepoints postdose (up to 24 hours) in Cycle 1

Secondary outcomes

  1. Change From the Time-matched Baseline in the Fridericia Correction of QTc (QTcF)

    Time frame: Baseline, Days 1 and 10 multiple timepoints postdose (up to 24 hours) in Cycle 1

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

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious 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 the first dose through 30 days after administration of the last dose of study drug (up to 328 days)

07

Results

Posted Mar 25, 2019

Participant flow

Participants took part in the study at 6 investigative sites in the United States from 25 June 2013 to 06 September 2016. Data cut-off for primary analysis was 04 August 2014.

Participant flow — Overall Study
MilestoneEsomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mg
Started2629
Completed1819
Not completed810
Withdrew: Didn't complete dosing;pk/ecg assessment810

Outcome measures

PrimaryCmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Esomeprazole
Time frame:
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
Reported as:
Mean · nmol/L
Cmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Esomeprazole
nmol/LAlisertib Without EsomeprazoleAlisertib With Esomeprazole
Cmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Esomeprazole1542.6 ± 357.191804.8 ± 571.89
Statistical analysis
  • Alisertib Without Esomeprazole vs Alisertib With Esomeprazole · Ls mean ratio: 1.14 · 90% CI 0.97 to 1.35Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.
PrimaryAUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Esomeprazole
Time frame:
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
Reported as:
Mean · hr*nmol/L
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Esomeprazole
hr*nmol/LAlisertib Without EsomeprazoleAlisertib With Esomeprazole
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Esomeprazole20427.8 ± 6813.4625094.4 ± 5574.04
Statistical analysis
  • Alisertib Without Esomeprazole vs Alisertib With Esomeprazole · Ls mean ratio: 1.25 · 90% CI 1.08 to 1.45Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.
PrimaryAUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence and Absence of Esomeprazole
Time frame:
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
Reported as:
Mean · hr*nmol/L
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence and Absence of Esomeprazole
hr*nmol/LAlisertib Without EsomeprazoleAlisertib With Esomeprazole
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence and Absence of Esomeprazole21371.4 ± 8138.5526612.5 ± 6626.40
Statistical analysis
  • Alisertib Without Esomeprazole vs Alisertib With Esomeprazole · Ls mean ratio: 1.28 · 90% CI 1.07 to 1.53Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.
PrimaryTmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Esomeprazole
Time frame:
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
Reported as:
Median · hours
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Esomeprazole
hoursAlisertib Without EsomeprazoleAlisertib With Esomeprazole
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Esomeprazole4.0 (2 to 8)3.0 (1 to 8)
PrimaryTerminal Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Esomeprazole
Time frame:
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
Reported as:
Mean · hours
Terminal Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Esomeprazole
hoursAlisertib Without EsomeprazoleAlisertib With Esomeprazole
Terminal Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Esomeprazole16.06 ± 5.39815.96 ± 5.234
PrimaryCmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Rifampin
Time frame:
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
Reported as:
Mean · nmol/L
Cmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Rifampin
nmol/LAlisertib Without RifampinAlisertib With Rifampin
Cmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Rifampin1561.4 ± 661.811581.5 ± 519.68
Statistical analysis
  • Alisertib Without Rifampin vs Alisertib With Rifampin · Ls mean ratio: 1.03 · 90% CI 0.84 to 1.26Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.
PrimaryAUC(Last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Rifampin
Time frame:
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
Reported as:
Mean · hr*nmol/L
AUC(Last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Rifampin
hr*nmol/LAlisertib Without RifampinAlisertib With Rifampin
AUC(Last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Rifampin19732.0 ± 8489.249470.5 ± 2653.60
Statistical analysis
  • Alisertib Without Rifampin vs Alisertib With Rifampin · Ls mean ratio: 0.51 · 90% CI 0.41 to 0.62Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.
PrimaryAUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence or Absence of Rifampin
Time frame:
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
Reported as:
Mean · hr*nmol/L
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence or Absence of Rifampin
hr*nmol/LAlisertib Without RifampinAlisertib With Rifampin
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence or Absence of Rifampin17258.3 ± 6163.608955.0 ± 2389.25
Statistical analysis
  • Alisertib Without Rifampin vs Alisertib With Rifampin · Ls mean ratio: 0.53 · 90% CI 0.41 to 0.70Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.
PrimaryTmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Rifampin
Time frame:
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
Reported as:
Median · hours
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Rifampin
hoursAlisertib Without RifampinAlisertib With Rifampin
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Rifampin4.0 (1 to 23)2.1 (1 to 6)
PrimaryPhase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Rifampin
Time frame:
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
Reported as:
Mean · hours
Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Rifampin
hoursAlisertib Without RifampinAlisertib With Rifampin
Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Rifampin16.30 ± 6.6088.17 ± 5.476
PrimaryChange From the Time-matched Baseline in the Individually Corrected QTc Interval (QTcI)
Time frame:
Baseline, Days 1 and 10 multiple timepoints postdose (up to 24 hours) in Cycle 1
Reported as:
Mean · milliseconds (msec)
Change From the Time-matched Baseline in the Individually Corrected QTc Interval (QTcI)
milliseconds (msec)Alisertib
Day 10, 0 hour postdose-2.2 (NA to 0.99)
Day 1, 0.5 hour postdose-3.7 (NA to -1.63)
Day 10, 0.5 hour postdose-5.4 (NA to -2.24)
Day 1, 1 hour postdose-4.5 (NA to -2.37)
Day 10, 1 hour postdose-3.5 (NA to -0.4)
Day 1, 2 hours postdose-4.0 (NA to -1.94)
Day 10, 2 hours postdose-1.6 (NA to 1.54)
Day 1, 3 hours postdose-2.5 (NA to -0.42)
Day 10, 3 hours postdose-2.3 (NA to 0.89)
Day 1, 4 hours postdose-1.2 (NA to 0.9)
Day 10, 4 hours postdose-1.2 (NA to 1.91)
Day 1, 6 hours postdose-0.9 (NA to 1.15)
Day 10, 6 hours postdose-3.5 (NA to -0.33)
Day 1, 8 hours postdose-0.5 (NA to 1.61)
Day 10, 8 hours postdose-0.4 (NA to 2.75)
Day 1, 10 hours postdose-1.5 (NA to 0.56)
Day 10, 10 hours postdose-2.4 (NA to 0.73)
Day 1, 24 hours postdose-3.3 (NA to -1.2)
SecondaryChange From the Time-matched Baseline in the Fridericia Correction of QTc (QTcF)
Time frame:
Baseline, Days 1 and 10 multiple timepoints postdose (up to 24 hours) in Cycle 1
Reported as:
Mean · milliseconds (msec)
Change From the Time-matched Baseline in the Fridericia Correction of QTc (QTcF)
milliseconds (msec)Alisertib
Day 10, 0 hour postdose-2.4 (NA to 0.7)
Day 1, 0.5 hour postdose-3.9 (NA to -1.8)
Day 10, 0.5 hour postdose-5.3 (NA to -2.19)
Day 1, 1 hour postdose-4.6 (NA to -2.54)
Day 10, 1 hour postdose-3.9 (NA to -0.76)
Day 1, 2 hours postdose-3.5 (NA to -1.51)
Day 10, 2 hours postdose-2.5 (NA to 0.63)
Day 1, 3 hours postdose-2.1 (NA to -0.09)
Day 10, 3 hours postdose-2.6 (NA to 0.55)
Day 1, 4 hours postdose0 (NA to 2.07)
Day 10, 4 hours postdose-1.3 (NA to 1.87)
Day 1, 6 hours postdose-0.5 (NA to 1.5)
Day 10, 6 hours postdose-4.1 (NA to -0.92)
Day 1, 8 hours postdose0 (NA to 2.1)
Day 10, 8 hours postdose-1.6 (NA to 1.54)
Day 1, 10 hours postdose-1.2 (NA to 0.9)
Day 10, 10 hours postdose-3.5 (NA to -0.3)
Day 1, 24 hours postdose-3.8 (NA to -1.72)
SecondaryNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious 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 the first dose through 30 days after administration of the last dose of study drug (up to 328 days)
Reported as:
Number · participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
participantsEsomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mg
AEs2527
SAEs911

Adverse events

Collected over From the first dose through 30 days after administration of the last dose of study drug (up to 328 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Esomeprazole 40 mg + Alisertib 50 mg1/26 (3.8%)9/26 (34.6%)25/26 (96.2%)
Rifampin 600 mg + Alisertib 50 mg3/29 (10.3%)11/29 (37.9%)25/29 (86.2%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventEsomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mg
VomitingGastrointestinal disorders1/262/29
NauseaGastrointestinal disorders0/262/29
Deep vein thrombosisVascular disorders0/262/29
Abdominal painGastrointestinal disorders1/261/29
ColitisGastrointestinal disorders1/260/29
AscitesGastrointestinal disorders1/260/29
Urinary tract infectionInfections and infestations1/260/29
Septic shockInfections and infestations1/260/29
Non-small cell lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/260/29
Cerebrovascular accidentNervous system disorders1/260/29
Most frequent other events
Showing 10 of 48
Most frequent other events
EventEsomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mg
DiarrhoeaGastrointestinal disorders15/264/29
AlopeciaSkin and subcutaneous tissue disorders14/266/29
FatigueGeneral disorders12/2610/29
StomatitisGastrointestinal disorders11/266/29
NeutropeniaBlood and lymphatic system disorders10/267/29
AnaemiaBlood and lymphatic system disorders7/268/29
VomitingGastrointestinal disorders7/265/29
NauseaGastrointestinal disorders7/264/29
Decreased appetiteMetabolism and nutrition disorders7/263/29
LeukopeniaBlood and lymphatic system disorders4/266/29

Baseline characteristics

The safety population included all participants who received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)Esomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mgTotal
Mean62.2 ± 6.9060.4 ± 10.5861.3 ± 8.99
Sex: Female, Male
Sex: Female, Male(Participants)Esomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mgTotal
Female142135
Male12820
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Esomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mgTotal
Hispanic or Latino347
Not Hispanic or Latino222446
Not Reported112
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Esomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mgTotal
White222648
Black or African American213
Native Hawaiian or Other Pacific Islander000
Asian000
American Indian or Alaska Native112
Other011
Not Reported101
Region of Enrollment
Region of Enrollment(Participants)Esomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mgTotal
United States262955
Height
Height(cm)Esomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mgTotal
Mean166.6 ± 8.90164.8 ± 9.09165.7 ± 8.97
Weight
Weight(kg)Esomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mgTotal
Mean82.07 ± 20.76577.37 ± 33.80179.59 ± 28.242
Body Mass Index
Body Mass Index(kg/m^2)Esomeprazole 40 mg + Alisertib 50 mgRifampin 600 mg + Alisertib 50 mgTotal
Mean29.557 ± 7.278728.026 ± 9.417528.750 ± 8.4327
08

Study locations

7 sites
  • Sarasota, Florida, United States
  • St Louis, Missouri, United States
  • Oklahoma City, Oklahoma, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • San Antonio, Texas, United States
  • Madison, Wisconsin, United States
09

Updates

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

Registry details

Key details

Study ID
NCT01844583
Lead sponsor
Millennium Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 1, 2013
Start date
Jun 25, 2013
Primary completion
Aug 4, 2014
Completion
Sep 6, 2016
Results posted
Mar 25, 2019
Last update
Mar 25, 2019

Study contacts

Medical Monitor
study director · Millennium Pharmaceuticals, Inc.
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: MLN 8237 · Esomeprazole · Rifampin

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