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A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00830518
Recruitment Status : Completed
First Posted : January 28, 2009
Results First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myelogenous Leukemia
High-Grade Myelodysplastic Syndrome
Intervention Drug: Alisertib
Enrollment 57
Recruitment Details Participants took part in the study at 19 investigative sites in France, Canada and the United States from 10 February 2009 to 04 July 2011.
Pre-assignment Details Participants with a diagnosis of acute myelogenous leukemia or myelodysplastic syndrome received 50 mg alisertib twice daily for 7 days in 21 day cycles. Results are reported according to lymphoma disease subtypes: acute myelogenous leukemia and myelodysplastic syndrome.
Arm/Group Title Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Hide Arm/Group Description Participants with acute myeloid leukemia received alisertib 50 mg, capsules, 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 26 Cycles). Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, 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 6 Cycles).
Period Title: Overall Study
Started 46 11
Completed 0 [1] 0
Not Completed 46 11
Reason Not Completed
Progressive Disease             18             8
Symptomatic Deterioration             4             1
Adverse Event             14             1
Withdrawal by Patient             2             0
Reason not Specified             8             1
[1]
Completed = participants who completed study treatment.
Arm/Group Title Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome) Total
Hide Arm/Group Description Participants with acute myeloid leukemia received alisertib 50 mg, capsules, 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 26 Cycles). Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, 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 6 Cycles). Total of all reporting groups
Overall Number of Baseline Participants 46 11 57
Hide Baseline Analysis Population Description
Safety population was defined as all participants who received any amount of alisertib.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 11 participants 57 participants
71.9  (7.41) 69.5  (12.50) 71.4  (8.54)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
<60 years Number Analyzed 46 participants 11 participants 57 participants
4 2 6
≥60 years Number Analyzed 46 participants 11 participants 57 participants
42 9 51
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 11 participants 57 participants
Female
22
  47.8%
3
  27.3%
25
  43.9%
Male
24
  52.2%
8
  72.7%
32
  56.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Hispanic or Latino Number Analyzed 46 participants 11 participants 57 participants
2 0 2
Not Hispanic or Latino Number Analyzed 46 participants 11 participants 57 participants
34 9 43
Not Reported Number Analyzed 46 participants 11 participants 57 participants
10 2 12
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 46 participants 11 participants 57 participants
36 10 46
Black or African American Number Analyzed 46 participants 11 participants 57 participants
3 0 3
Asian Number Analyzed 46 participants 11 participants 57 participants
1 0 1
Not Reported Number Analyzed 46 participants 11 participants 57 participants
6 1 7
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 11 participants 57 participants
33 9 42
France Number Analyzed 46 participants 11 participants 57 participants
11 2 13
Canada Number Analyzed 46 participants 11 participants 57 participants
2 0 2
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 36 participants 10 participants 46 participants
165.8  (8.35) 171.4  (9.98) 167.0  (8.93)
[1]
Measure Analysis Population Description: Baseline height data is available for n=36,10 participants, respectively.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 45 participants 11 participants 56 participants
73.7  (13.80) 80.4  (17.27) 75.0  (14.62)
[1]
Measure Analysis Population Description: Baseline weight data is available for n=45,11 participants, respectively.
Baseline Body Surface Area (BSA)   [1] 
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 36 participants 10 participants 46 participants
1.83  (0.203) 1.94  (0.262) 1.86  (0.219)
[1]
Measure Analysis Population Description: Baseline BSA data is available for n=36,10 participants, respectively.
Years Since Initial Diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 11 participants 57 participants
0.65  (0.793) 0.82  (0.780) 0.68  (0.787)
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
0 Number Analyzed 46 participants 11 participants 57 participants
9 3 12
1 Number Analyzed 46 participants 11 participants 57 participants
29 8 37
2 Number Analyzed 46 participants 11 participants 57 participants
8 0 8
[1]
Measure Description: ECOG performance is defined as: 0=Normal activity (fully active, able to carry on all predisease performance without restriction); 1=Symptoms but ambulatory (restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature); 2=In bed <50% of the time (ambulatory and capable of all self-care, but unable to carry out any work activities.
1.Primary Outcome
Title Best Overall Response Rate (ORR) Based on Investigator’s Assessment
Hide Description Best ORR is defined as the number of participants with complete remission(CR) or partial remission(PR) assessed by the Investigator using modified AML/MDS International Working Group(IWG) Criteria. AML:CR=neutrophils >1x10^9/L, platelets >100x10^9/L, bone marrow blasts(BMB) <5%, transfusion independent, no extramedullary disease(EMD); CRi=BMB <5%, transfusion independent, no EMD; PR=neutrophils >1x10^9/L, platelets >100x10^9/L, BMB >50% decrease and 5% to 25%, blasts <5% with Auer rods; PRi=BMB >50% decrease and 5% to 25%. MDS:CR=bone marrow: ≤5% myeloblasts with normal maturation, peripheral blood: hemoglobin ≥11 g/dL, platelets ≥100x10^9/L, neutrophils ≥1.0x10^9/L, blasts 0%; PR=all CR criteria if abnormal before treatment except: BMB decreased by ≥50% over pretreatment but still >5%; PRi=BMB decreased by ≥50% over pretreatment but still >5%; Marrow CR=bone marrow: ≤5% myeloblasts and decrease by ≥50% over pretreatment, peripheral blood hematologic improvement responses noted.
Time Frame Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population included all participants who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment. In 2 participants disease transformed from MDS to AML. One participant is considered AML and one participant is considered MDS in the calculation, based on the timing of their transformation.
Arm/Group Title Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Hide Arm/Group Description:
Participants with acute myeloid leukemia received alisertib 50 mg, capsules, 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 26 Cycles).
Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, 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 6 Cycles).
Overall Number of Participants Analyzed 35 10
Measure Type: Number
Unit of Measure: participants
CR + PR 6 0
Complete Remission (CR + CRi + Marrow CRi) 1 0
Partial Remission (PR + PRi) 5 0
Stable Disease as Best Response 17 2
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS is defined as the time from the date of first study drug administration to the date of first documented progressive disease (PD) or death.
Time Frame Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-Evaluable Population included all participants who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better.
Arm/Group Title Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Hide Arm/Group Description:
Participants with acute myeloid leukemia received alisertib 50 mg, capsules, 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 26 Cycles).
Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, 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 6 Cycles).
Overall Number of Participants Analyzed 35 10
Median (95% Confidence Interval)
Unit of Measure: days
55.0
(47.0 to 67.0)
38.0
(35.0 to 113.0)
3.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Duration of response is defined as the time from the date of first documentation of a response to the date of first documented PD.
Time Frame Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-­Evaluable Population included all participants who had measurable disease, received at least 1 dose of alisertib, and had at least 1 post baseline response assessment. All responders were evaluated in this outcome measure. For a participant that has not progressed, DOR is censored at the last response assessment that is SD or better.
Arm/Group Title Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Hide Arm/Group Description:
Participants with acute myeloid leukemia received alisertib 50 mg, capsules, 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 26 Cycles).
Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, 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 6 Cycles).
Overall Number of Participants Analyzed 6 0
Median (95% Confidence Interval)
Unit of Measure: days
409.0
(57.0 to 596.0)
4.Secondary Outcome
Title Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment
Hide Description Best overall HI response is defined as percentage of participants with response as assessed by Investigator based on IWG criteria: 1)Erythroid response (pretreatment,<11 g/dL): hemoglobin (Hgb) increase by ≥1.5 g/dL, relevant reduction of units of red blood cell (RBC) transfusions by absolute number of at least 4 RBC transfusions/8 weeks compared to pretreatment transfusion number in previous 8 weeks. Only RBC transfusions given for Hgb of ≤9.0 g/dL pretreatment will count in RBC transfusion response evaluation. 2)Platelet response (pretreatment,<100x10^9/L):Absolute increase of ≥30x10^9/L for participants starting->20x10^9/L platelets, increase <20x10^9/L to >20x10^9/L by at least 100%. 3)Neutrophil response (pretreatment,<1.0x10^9/L):At least 100% increase and an absolute increase >0.5x10^9/L. 4)Progression or relapse after HI:At least 1 of following: 50% decrement from maximum response levels in granulocytes or platelets, or reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.
Time Frame Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received any amount of alisertib.
Arm/Group Title Alisertib 50 mg (Myelodysplastic Syndrome)
Hide Arm/Group Description:
Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, 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 6 Cycles).
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of participants
Erythroid Response 0
Platelet Response 0
Neutrophil Response 0
Progression or Relapse 0
Not Available 91
Unable to Assess 9
5.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths
Hide Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator.
Time Frame First dose of study drug to 30 days after last dose (Up to 18.9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received any amount of alisertib.
Arm/Group Title Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Hide Arm/Group Description:
Participants with acute myeloid leukemia received alisertib 50 mg, capsules, 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 26 Cycles).
Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, 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 6 Cycles).
Overall Number of Participants Analyzed 46 11
Measure Type: Number
Unit of Measure: participants
AE 46 11
SAE 36 8
Deaths 20 2
6.Secondary Outcome
Title Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events
Hide Description Vital signs measurements (blood pressure, heart rate, and oral temperature) were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame First dose of study drug to 30 days after last dose (Up to 18.9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received any amount of alisertib.
Arm/Group Title Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Hide Arm/Group Description:
Participants with acute myeloid leukemia received alisertib 50 mg, capsules, 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 26 Cycles).
Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, 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 6 Cycles).
Overall Number of Participants Analyzed 46 11
Measure Type: Number
Unit of Measure: participants
Dyspnoea 12 2
Pyrexia 10 2
Hypotension 8 0
Atrial fibrillation 4 1
Tachycardia 3 0
Dyspnoea exertional 2 1
Hypertension 1 1
Supraventricular tachycardia 2 0
Weight decreased 2 0
Tachypnoea 1 0
Hyperthermia 1 0
Hypothermia 1 0
Bradycardia 0 1
Ventricular tachycardia 1 0
7.Secondary Outcome
Title Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Hide Description Abnormal Laboratory Values for Chemistry or Hematology tests that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. A treatment­-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame First dose of study drug to 30 days after last dose (Up to 18.9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all participants who received any amount of alisertib.
Arm/Group Title Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Hide Arm/Group Description:
Participants with acute myeloid leukemia received alisertib 50 mg, capsules, 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 26 Cycles).
Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, 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 6 Cycles).
Overall Number of Participants Analyzed 46 11
Measure Type: Number
Unit of Measure: participants
Febrile neutropenia 17 4
Anaemia 14 3
Thrombocytopenia 9 2
Neutropenia 5 3
Leukopenia 3 2
Hypoalbuminaemia 4 0
Leukocytosis 3 0
Hypokalaemia 3 0
Hyponatraemia 3 0
Neutrophil count decreased 3 0
Hypocalcaemia 2 0
Clostridium difficile colitis 2 0
Febrile bone marrow aplasia 1 0
Hypoxia 1 0
Hyperkalaemia 1 0
Hypernatraemia 1 0
Hyperglycaemia 1 0
Hypoglycaemia 1 0
Hypomagnesaemia 0 1
Hypophospataemia 1 0
Alanine aminotransferase increased 0 1
Blood bilirubin increased 1 0
Oxygen saturation decreased 1 0
Blood culture positive 1 0
Blood magnesium decreased 1 0
Blood creatinine increased 1 0
White blood cell count decreased 1 0
Gilbert’s syndrome 1 0
Lymphoedema 1 0
Platelet count decreased 1 0
Time Frame First dose of study drug to 30 days after last dose (Up to 18.9 Months)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Hide Arm/Group Description Participants with acute myeloid leukemia received alisertib 50 mg, capsules, 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 26 Cycles). Participants with myelodysplastic syndrome received alisertib 50 mg, capsules, 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 6 Cycles).
All-Cause Mortality
Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Affected / at Risk (%) Affected / at Risk (%)
Total   36/46 (78.26%)   8/11 (72.73%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  13/46 (28.26%)  4/11 (36.36%) 
Anaemia  2  4/46 (8.70%)  0/11 (0.00%) 
Febrile bone marrow aplasia  2  1/46 (2.17%)  0/11 (0.00%) 
Thrombocytopenia  2  1/46 (2.17%)  0/11 (0.00%) 
Cardiac disorders     
Atrial fibrillation  2  0/46 (0.00%)  1/11 (9.09%) 
Supraventricular tachycardia  2  1/46 (2.17%)  0/11 (0.00%) 
Pericardial effusion  2  1/46 (2.17%)  0/11 (0.00%) 
Myocardial infarction  2  0/46 (0.00%)  1/11 (9.09%) 
Ear and labyrinth disorders     
Deafness unilateral  2  1/46 (2.17%)  0/11 (0.00%) 
Gastrointestinal disorders     
Stomatitis  2  2/46 (4.35%)  1/11 (9.09%) 
Gastrointestinal haemorrhage  2  1/46 (2.17%)  0/11 (0.00%) 
Melaena  2  1/46 (2.17%)  0/11 (0.00%) 
Diarrhoea  2  1/46 (2.17%)  0/11 (0.00%) 
Abdominal pain  2  1/46 (2.17%)  0/11 (0.00%) 
Constipation  2  0/46 (0.00%)  1/11 (9.09%) 
Gastrointestinal inflammation  2  0/46 (0.00%)  1/11 (9.09%) 
Dysphagia  2  1/46 (2.17%)  0/11 (0.00%) 
Rectal haemorrhage  2  1/46 (2.17%)  0/11 (0.00%) 
Mouth haemorrhage  2  1/46 (2.17%)  0/11 (0.00%) 
Ascites  2  1/46 (2.17%)  0/11 (0.00%) 
General disorders     
Disease progression  2  4/46 (8.70%)  1/11 (9.09%) 
Fatigue  2  1/46 (2.17%)  1/11 (9.09%) 
General physical health deterioration  2  1/46 (2.17%)  0/11 (0.00%) 
Multi-organ failure  2  0/46 (0.00%)  1/11 (9.09%) 
Asthenia  2  1/46 (2.17%)  0/11 (0.00%) 
Hyperthermia  2  1/46 (2.17%)  0/11 (0.00%) 
Pyrexia  2  1/46 (2.17%)  0/11 (0.00%) 
Infections and infestations     
Sepsis  2  5/46 (10.87%)  2/11 (18.18%) 
Pneumonia  2  4/46 (8.70%)  0/11 (0.00%) 
Bacteraemia  2  1/46 (2.17%)  1/11 (9.09%) 
Bacterial infection  2  1/46 (2.17%)  1/11 (9.09%) 
Bacterial sepsis  2  1/46 (2.17%)  0/11 (0.00%) 
Septic shock  2  1/46 (2.17%)  0/11 (0.00%) 
Cellulitis  2  1/46 (2.17%)  0/11 (0.00%) 
Gastrointestinal infection  2  1/46 (2.17%)  0/11 (0.00%) 
Vulvovaginal mycotic infection  2  1/46 (2.17%)  0/11 (0.00%) 
Serratia bacteraemia  2  1/46 (2.17%)  0/11 (0.00%) 
Injury, poisoning and procedural complications     
Subdural haematoma  2  1/46 (2.17%)  0/11 (0.00%) 
Hip fracture  2  1/46 (2.17%)  0/11 (0.00%) 
Fall  2  0/46 (0.00%)  1/11 (9.09%) 
Spinal compression fracture  2  0/46 (0.00%)  1/11 (9.09%) 
Transfusion reaction  1  1/46 (2.17%)  0/11 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  2  2/46 (4.35%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  2  1/46 (2.17%)  0/11 (0.00%) 
Arthralgia  2  1/46 (2.17%)  0/11 (0.00%) 
Neck mass  2  1/46 (2.17%)  0/11 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  2  5/46 (10.87%)  0/11 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage  2  1/46 (2.17%)  0/11 (0.00%) 
Haemorrhage intracranial  2  1/46 (2.17%)  0/11 (0.00%) 
Depressed level of consciousness  2  1/46 (2.17%)  0/11 (0.00%) 
Somnolence  2  1/46 (2.17%)  0/11 (0.00%) 
Dizziness  2  1/46 (2.17%)  0/11 (0.00%) 
Renal and urinary disorders     
Renal failure acute  2  2/46 (4.35%)  0/11 (0.00%) 
Cystitis haemorrhagic  2  1/46 (2.17%)  0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  2  2/46 (4.35%)  1/11 (9.09%) 
Respiratory distress  2  1/46 (2.17%)  0/11 (0.00%) 
Hypoxia  2  1/46 (2.17%)  0/11 (0.00%) 
Respiratory failure  2  1/46 (2.17%)  0/11 (0.00%) 
Vascular disorders     
Hypotension  2  1/46 (2.17%)  0/11 (0.00%) 
Hypertension  2  1/46 (2.17%)  1/11 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alisertib 50 mg (Acute Myeloid Leukemia) Alisertib 50 mg (Myelodysplastic Syndrome)
Affected / at Risk (%) Affected / at Risk (%)
Total   45/46 (97.83%)   11/11 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  10/46 (21.74%)  3/11 (27.27%) 
Thrombocytopenia  1  8/46 (17.39%)  2/11 (18.18%) 
Neutropenia  1  5/46 (10.87%)  3/11 (27.27%) 
Febrile neutropenia  1  6/46 (13.04%)  0/11 (0.00%) 
Leukopenia  1  3/46 (6.52%)  2/11 (18.18%) 
Leukocytosis  1  3/46 (6.52%)  0/11 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  4/46 (8.70%)  0/11 (0.00%) 
Tachycardia  1  3/46 (6.52%)  0/11 (0.00%) 
Bradycardia  1  0/46 (0.00%)  1/11 (9.09%) 
Ear and labyrinth disorders     
Tinnitus  1  3/46 (6.52%)  0/11 (0.00%) 
Eye disorders     
Vision blurred  1  1/46 (2.17%)  1/11 (9.09%) 
Gastrointestinal disorders     
Diarrhoea  1  21/46 (45.65%)  2/11 (18.18%) 
Nausea  1  19/46 (41.30%)  3/11 (27.27%) 
Stomatitis  1  13/46 (28.26%)  4/11 (36.36%) 
Vomiting  1  8/46 (17.39%)  2/11 (18.18%) 
Dysphagia  1  6/46 (13.04%)  0/11 (0.00%) 
Abdominal pain upper  1  4/46 (8.70%)  0/11 (0.00%) 
Constipation  1  3/46 (6.52%)  1/11 (9.09%) 
Gingival bleeding  1  4/46 (8.70%)  0/11 (0.00%) 
Oral pain  1  4/46 (8.70%)  0/11 (0.00%) 
Haemorrhoids  1  2/46 (4.35%)  1/11 (9.09%) 
Proctalgia  1  2/46 (4.35%)  1/11 (9.09%) 
Abdominal distension  1  1/46 (2.17%)  1/11 (9.09%) 
Dyspepsia  1  1/46 (2.17%)  1/11 (9.09%) 
Tongue ulceration  1  1/46 (2.17%)  1/11 (9.09%) 
Anal fissure  1  0/46 (0.00%)  1/11 (9.09%) 
Oral disorder  1  0/46 (0.00%)  1/11 (9.09%) 
Abdominal pain  1  11/46 (23.91%)  2/11 (18.18%) 
General disorders     
Fatigue  1  15/46 (32.61%)  5/11 (45.45%) 
Oedema peripheral  1  12/46 (26.09%)  0/11 (0.00%) 
Pyrexia  1  9/46 (19.57%)  2/11 (18.18%) 
Asthenia  1  8/46 (17.39%)  1/11 (9.09%) 
Chills  1  6/46 (13.04%)  1/11 (9.09%) 
Axillary pain  1  0/46 (0.00%)  1/11 (9.09%) 
Catheter site erythema  1  0/46 (0.00%)  1/11 (9.09%) 
Non-cardiac chest pain  1  0/46 (0.00%)  1/11 (9.09%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/46 (0.00%)  1/11 (9.09%) 
Infections and infestations     
Oral herpes  1  4/46 (8.70%)  1/11 (9.09%) 
Cellulitis  1  3/46 (6.52%)  1/11 (9.09%) 
Pneumonia  1  3/46 (6.52%)  0/11 (0.00%) 
Bronchitis  1  1/46 (2.17%)  1/11 (9.09%) 
Anal abscess  1  0/46 (0.00%)  1/11 (9.09%) 
Aspergillosis  1  0/46 (0.00%)  1/11 (9.09%) 
Nasopharyngitis  1  0/46 (0.00%)  1/11 (9.09%) 
Oral candidiasis  1  0/46 (0.00%)  1/11 (9.09%) 
Injury, poisoning and procedural complications     
Contusion  1  2/46 (4.35%)  3/11 (27.27%) 
Excoriation  1  0/46 (0.00%)  1/11 (9.09%) 
Investigations     
Neutrophil count decreased  1  3/46 (6.52%)  0/11 (0.00%) 
Alanine aminotransferase increased  1  0/46 (0.00%)  1/11 (9.09%) 
Metabolism and nutrition disorders     
Decreased appetite  1  8/46 (17.39%)  0/11 (0.00%) 
Hypoalbuminaemia  1  4/46 (8.70%)  0/11 (0.00%) 
Hypokalaemia  1  3/46 (6.52%)  0/11 (0.00%) 
Hyponatraemia  1  3/46 (6.52%)  0/11 (0.00%) 
Dehydration  1  1/46 (2.17%)  1/11 (9.09%) 
Hypomagnesaemia  1  0/46 (0.00%)  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  3/46 (6.52%)  2/11 (18.18%) 
Neck pain  1  3/46 (6.52%)  0/11 (0.00%) 
Pain in extremity  1  3/46 (6.52%)  0/11 (0.00%) 
Arthralgia  1  1/46 (2.17%)  1/11 (9.09%) 
Myalgia  1  1/46 (2.17%)  1/11 (9.09%) 
Gouty arthritis  1  0/46 (0.00%)  1/11 (9.09%) 
Nervous system disorders     
Somnolence  1  11/46 (23.91%)  2/11 (18.18%) 
Headache  1  5/46 (10.87%)  2/11 (18.18%) 
Balance disorder  1  0/46 (0.00%)  1/11 (9.09%) 
Burning sensation  1  0/46 (0.00%)  1/11 (9.09%) 
Depressed level of consciousness  1  0/46 (0.00%)  1/11 (9.09%) 
Subdural hygroma  1  0/46 (0.00%)  1/11 (9.09%) 
Dizziness  1  4/46 (8.70%)  2/11 (18.18%) 
Psychiatric disorders     
Anxiety  1  4/46 (8.70%)  0/11 (0.00%) 
Confusional state  1  2/46 (4.35%)  1/11 (9.09%) 
Mental status changes  1  0/46 (0.00%)  1/11 (9.09%) 
Psychotic disorder  1  0/46 (0.00%)  1/11 (9.09%) 
Renal and urinary disorders     
Haematuria  1  3/46 (6.52%)  0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  9/46 (19.57%)  3/11 (27.27%) 
Epistaxis  1  5/46 (10.87%)  3/11 (27.27%) 
Oropharyngeal pain  1  3/46 (6.52%)  3/11 (27.27%) 
Pleural effusion  1  4/46 (8.70%)  0/11 (0.00%) 
Dyspnoea exertional  1  2/46 (4.35%)  1/11 (9.09%) 
Sneezing  1  0/46 (0.00%)  1/11 (9.09%) 
Dyspnoea  1  10/46 (21.74%)  2/11 (18.18%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  7/46 (15.22%)  4/11 (36.36%) 
Petechiae  1  4/46 (8.70%)  0/11 (0.00%) 
Pruritus  1  2/46 (4.35%)  2/11 (18.18%) 
Blood blister  1  1/46 (2.17%)  2/11 (18.18%) 
Ecchymosis  1  3/46 (6.52%)  0/11 (0.00%) 
Night sweats  1  3/46 (6.52%)  0/11 (0.00%) 
Rash  1  2/46 (4.35%)  1/11 (9.09%) 
Rash pruritic  1  2/46 (4.35%)  1/11 (9.09%) 
Urticaria  1  3/46 (6.52%)  0/11 (0.00%) 
Rash macular  1  0/46 (0.00%)  1/11 (9.09%) 
Vascular disorders     
Hypotension  1  7/46 (15.22%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor’s confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT00830518     History of Changes
Other Study ID Numbers: C14005
2008-006977-34 ( EudraCT Number )
U1111-1187-6569 ( Registry Identifier: WHO )
First Submitted: January 27, 2009
First Posted: January 28, 2009
Results First Submitted: January 4, 2018
Results First Posted: May 11, 2018
Last Update Posted: May 11, 2018