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CompletedNCT01714947Updated Oct 31, 2018Results posted

Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib

A Phase 1 interventional study of [^14C]-alisertib and alisertib in Advanced Solid Tumors and Lymphoma, sponsored by Millennium Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-31.

Sponsored by Millennium Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity [TRA] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood.

Read the detailed description

The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat participants who have advanced solid tumors or lymphomas. This study looked at mass balance, pharmacokinetics (PK), metabolism, elimination and safety of alisertib.

The study enrolled 3 patients. The study consisted of 2 parts: Part A and Part B. Participants received:

  • [\^14C]-alisertib 35 mg in Part A
  • alisertib 50 mg in Part B

Participants were asked to take a single dose of [\^14C]-alisertib oral solution containing 80-100 μCi of total radioactivity (1.19-1.48 mCi/mmol) in Part A and alisertib 50 mg, orally, twice daily for 7 days in 21-day cycles until disease progression or unacceptable toxicity in Part B.

This single center trial was conducted in United States. The overall time to participate in this study was up to 117 days. Participants remained confined to clinic in Part A and made multiple visits to the clinic in Part B. Participants were contacted 30 days after last dose of alisertib in Part A (if not continuing in Part B), or were contacted by telephone or a final visit 30 days after receiving their last dose of alisertib in Part B for a follow-up assessment.

02

Conditions studied

  • Advanced Solid Tumors
  • Lymphoma

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Keywords

  • Drug Therapy
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 3 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Millennium Pharmaceuticals, Inc. is the lead sponsor of 173 studies on the registry; none are open to participants now.

Of its 73 completed or terminated interventional studies of FDA-regulated products, 72 (99%) have results posted.

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

Inclusion criteria

Each participants must meet all of the following inclusion criteria to be enrolled in the study:

  • 18 years or older.
  • Histologically or cytologically confirmed metastatic and/or advanced solid 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.
  • Expected survival longer than 3 months from enrollment in the study.
  • Radiographically or clinically evaluable tumor.
  • Suitable venous access for the conduct of blood sampling.
  • Recovered from the reversible effects of prior antineoplastic treatment (with the exception of alopecia and Grade 1 neuropathy).
  • 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.
  • 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 abstain from heterosexual intercourse.

Exclusion criteria

Exclusion Criteria:

Participants meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Female participants who are lactating or have a positive serum pregnancy test.
  • Treatment with any investigational products or systemic antineoplastic treatment within 21 days before the first dose of alisertib.
  • 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 within 24 hours preceding the first dose of alisertib.
  • Participants requiring systemic anticoagulation (excluding low-dose aspirin, or low-dose anticoagulation to maintain patency of venous access devices). Low molecular weight heparin, administered as preventive treatment, is allowed if the participant has tolerated treatment with a stable dose and schedule without bleeding complications for more than 1 month.
  • Major surgery within the 14 days preceding the first dose of alisertib.
  • Infection requiring systemic intravenous (IV) antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection.
  • Life-threatening or uncontrolled medical illness unrelated to cancer.
  • Ongoing nausea or vomiting that is Grade 2 or worse in intensity.
  • Diarrhea that is Grade 2 or worse in intensity or use of an antimotility agent to control diarrhea to an intensity of Grade 1 or lower level.
  • Known GI disease or GI procedures that could interfere with the oral absorption, excretion, or tolerance of alisertib.
  • History of urinary and/or fecal incontinence.
  • History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease.
  • Inability to swallow tablets, or inability or unwillingness to avoid taking anything by mouth except for water and prescribed medications for 2 hours before and 1 hour after the first dose of alisertib.
  • Inadequate bone marrow or other organ function as specified in study protocol.
  • Any cardiovascular condition specified in the study protocol.
  • Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
  • Inability to comply with study visits and procedures including required inpatient confinement (approximately 11-17 days).

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Alisertib

    Part A: \[\^14C\]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).

    Drug: [^14C]-alisertib · Drug: alisertib

Interventions

  • Drug[^14C]-alisertib

    \[\^14C\]-alisertib oral solution

    Also known as: MLN8237

  • Drugalisertib

    Alisertib enteric coated tablets

    Also known as: MLN8237

06

What researchers measure

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  2. Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  3. AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  4. AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  5. T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  6. CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  7. Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  8. Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  9. Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  10. Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  11. Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  12. Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  13. Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  14. Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  15. Ae: Amount of [^14C]-Alisertib Excreted in Urine

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  16. Ae: Amount of [^14C]-Alisertib Excreted in Feces

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  17. Percent of Total Radioactivity (TRA) in Urine and Feces

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  18. Fe: Fraction of Administered Dose of Alisertib Excreted in Urine

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  19. Ae: Amount of Alisertib Excretion in Urine

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

  20. Renal Clearance (CLR) of Alisertib

    Time frame: Predose and multiple timepoints post-dose (up to 240 hours)

Secondary outcomes

  1. Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution

    Total radioactive peak distributions of metabolites in 0 to 192 hours pooled plasma samples from participants.

    Time frame: Predose and multiple timepoints post-dose (0 to 192 hours)

  2. Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution

    Total radioactive peak distributions of metabolites in 0 to 192 hours pooled urine samples from participants.

    Time frame: Predose and multiple timepoints post-dose (0 to 192 hours)

  3. Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution

    Total radioactive peak distributions of metabolites in 0 to 192 hours pooled fecal samples from participants.

    Time frame: Predose and multiple timepoints post-dose (0 to 192 hours)

  4. Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events

    An Adverse Event (AE) was 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) was defined as any AE at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity or resulted in congenital anomaly/birth defect. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.

    Time frame: From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days)

  5. Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs

    An abnormal laboratory was assessed to be an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from Baseline.

    Time frame: Part A: Day 1 and End of Study (EOS) Day 31 if not continuing to Part B, Part B: Days 8 and 15 of each cycle and EOS (Up to 117 days)

  6. Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements

    Vital signs included body temperature, heart rate, and sitting blood pressure. The investigator determined if the changes were clinically significant.

    Time frame: Part A: Day 1 and EOS (Day 31 if not continuing to Part B), Part B: Day 1 of each cycle and EOS (Up to 117 days)

07

Results

Posted Oct 31, 2018

Participant flow

Participants took part in the study at 1 investigative site in the United States from 24 January 2013 to 14 June 2013.

Part A
Participant flow — Part A
MilestoneAlisertib
Started3
Completed3
Not completed0
Part B
Participant flow — Part B
MilestoneAlisertib
Started3
Completed0
Not completed3
Withdrew: Progressive disease3

Outcome measures

PrimaryCmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · nanomole (nmol)/liter (L)
Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
nanomole (nmol)/liter (L)Alisertib
Alisertib2183.3 ± 161.97
Drug-Related Material2606.7 ± 228.98
PrimaryTmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Median · hr
Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
hrAlisertib
Alisertib1.00 ± 161.97
Drug-Related Material1.00 ± 228.98
PrimaryAUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · hour (hr)*nmol/L
AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
hour (hr)*nmol/LAlisertib
Alisertib16800.0 ± 4936.60
Drug-Related Material37033.3 ± 20545.15
PrimaryAUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · hr*nmol/L
AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
hr*nmol/LAlisertib
Alisertib17266.7 ± 5138.42
Drug-Related Material42233.3 ± 23302.43
PrimaryT1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · hour
T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
hourAlisertib
Alisertib23.40 ± 7.041
Drug-Related Material42.03 ± 25.255
PrimaryCL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Geometric mean · L/hr
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution
L/hrAlisertib
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution4.06 ± 25.6
PrimaryRatio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · ratio
Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax
ratioAlisertib
Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax0.6550 ± 0.0671
PrimaryRatio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · ratio
Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax
ratioAlisertib
Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax0.8397 ± 0.0589
PrimaryRatio of Whole Blood TRA AUClast to Plasma TRA AUClast
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · ratio
Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast
ratioAlisertib
Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast0.5950 ± 0.1010
PrimaryRatio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · ratio
Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast
ratioAlisertib
Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast0.4997 ± 0.1364
PrimaryRatio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · ratio
Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞
ratioAlisertib
Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞0.6750 ± 0.0170
PrimaryRatio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · ratio
Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞
ratioAlisertib
Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞0.4490 ± 0.1204
PrimaryFe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · percent of dose
Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine
percent of doseAlisertib
Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine2.650 ± 1.7935
PrimaryFe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · percent of dose
Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces
percent of doseAlisertib
Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces87.833 ± 2.2898
PrimaryAe: Amount of [^14C]-Alisertib Excreted in Urine
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · nanogram equivalent [ng(eq)]
Ae: Amount of [^14C]-Alisertib Excreted in Urine
nanogram equivalent [ng(eq)]Alisertib
Ae: Amount of [^14C]-Alisertib Excreted in Urine939420.7 ± 632770.92
PrimaryAe: Amount of [^14C]-Alisertib Excreted in Feces
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · ng(eq)
Ae: Amount of [^14C]-Alisertib Excreted in Feces
ng(eq)Alisertib
Ae: Amount of [^14C]-Alisertib Excreted in Feces31156703.0 ± 764243.97
PrimaryPercent of Total Radioactivity (TRA) in Urine and Feces
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · percent of TRA
Percent of Total Radioactivity (TRA) in Urine and Feces
percent of TRAAlisertib
Percent of Total Radioactivity (TRA) in Urine and Feces90.500 ± 1.3115
PrimaryFe: Fraction of Administered Dose of Alisertib Excreted in Urine
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · percent of dose
Fe: Fraction of Administered Dose of Alisertib Excreted in Urine
percent of doseAlisertib
Fe: Fraction of Administered Dose of Alisertib Excreted in Urine0.009045 ± 0.000714
PrimaryAe: Amount of Alisertib Excretion in Urine
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · ng
Ae: Amount of Alisertib Excretion in Urine
ngAlisertib
Ae: Amount of Alisertib Excretion in Urine3215.0 ± 219.20
PrimaryRenal Clearance (CLR) of Alisertib
Time frame:
Predose and multiple timepoints post-dose (up to 240 hours)
Reported as:
Mean · L/hr
Renal Clearance (CLR) of Alisertib
L/hrAlisertib
Renal Clearance (CLR) of Alisertib0.000687 ± 0.000013
SecondaryPercentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution

Total radioactive peak distributions of metabolites in 0 to 192 hours pooled plasma samples from participants.

Time frame:
Predose and multiple timepoints post-dose (0 to 192 hours)
Reported as:
Number · percent of plasma AUC0-192hr
Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
percent of plasma AUC0-192hrAlisertib
Metabolite M112.0
Metabolite M234.6
Metabolite M35.6
SecondaryPercentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution

Total radioactive peak distributions of metabolites in 0 to 192 hours pooled urine samples from participants.

Time frame:
Predose and multiple timepoints post-dose (0 to 192 hours)
Reported as:
Number · percent of dose
Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution
percent of doseAlisertib
Unknown0.24
M8a0.28
M90.66
M5360.14
M10.84
M80.37
Others0.05
SecondaryPercentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution

Total radioactive peak distributions of metabolites in 0 to 192 hours pooled fecal samples from participants.

Time frame:
Predose and multiple timepoints post-dose (0 to 192 hours)
Reported as:
Number · percent of dose
Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution
percent of doseAlisertib
M5364.45
M520a1.19
M3a2.22
M5502.96
M5379.17
M520b1.72
M320.82
M520c5.94
Alisertib26.27
M28.62
Others0
SecondaryNumber of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events

An Adverse Event (AE) was 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) was defined as any AE at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity or resulted in congenital anomaly/birth defect. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.

Time frame:
From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days)
Reported as:
Number · Participants
Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
ParticipantsAlisertib
Any AE3
SAE0
SecondaryNumber of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs

An abnormal laboratory was assessed to be an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from Baseline.

Time frame:
Part A: Day 1 and End of Study (EOS) Day 31 if not continuing to Part B, Part B: Days 8 and 15 of each cycle and EOS (Up to 117 days)
Reported as:
Number · Participants
Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs
ParticipantsAlisertib
Neutrophil Count Decreased1
Neutropenia1
Blood Magnesium Decreased1
SecondaryNumber of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements

Vital signs included body temperature, heart rate, and sitting blood pressure. The investigator determined if the changes were clinically significant.

Time frame:
Part A: Day 1 and EOS (Day 31 if not continuing to Part B), Part B: Day 1 of each cycle and EOS (Up to 117 days)
Reported as:
Number · Participants
Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements
ParticipantsAlisertib
Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements0

Adverse events

Collected over From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alisertib—0/3 (0%)3/3 (100%)
Most frequent other events
Showing 10 of 19
Most frequent other events
EventAlisertib
FatigueGeneral disorders2/3
AlopeciaSkin and subcutaneous tissue disorders2/3
NauseaGastrointestinal disorders1/3
VomitingGastrointestinal disorders1/3
GlossodyniaGastrointestinal disorders1/3
PyrexiaGeneral disorders1/3
ChillsGeneral disorders1/3
Oedema peripheralGeneral disorders1/3
Back painMusculoskeletal and connective tissue disorders1/3
Musculoskeletal painMusculoskeletal and connective tissue disorders1/3

Baseline characteristics

Safety Population included all participants who received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)Alisertib
Mean64.0 ± 13.11
Sex: Female, Male
Sex: Female, Male(Participants)Alisertib
Female1
Male2
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Alisertib
Not Hispanic or Latino3
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Alisertib
White2
Black or African American1
Region of Enrollment
Region of Enrollment(participants)Alisertib
United States3
Height
Height(cm)Alisertib
Mean173.5 ± 7.15
Weight
Weight(kg)Alisertib
Mean80.27 ± 20.760
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Alisertib
Mean26.91 ± 8.346
08

Study locations

1 site
  • Comprehensive Clinical Development
    Tacoma, Washington 98418, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01714947
Lead sponsor
Millennium Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Oct 26, 2012
Start date
Jan 24, 2013
Primary completion
Apr 4, 2013
Completion
Jun 14, 2013
Results posted
Oct 31, 2018
Last update
Oct 31, 2018

Study contacts

Medical Director Clinical Science
study director · Takeda

Oversight

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

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

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Other studies from this sponsor

Millennium Pharmaceuticals, Inc.

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