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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Alisertib 50 mg (Acute Myeloid Leukemia) 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).
Alisertib 50 mg (Myelodysplastic Syndrome) 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).

Participant Flow:   Overall Study
    Alisertib 50 mg (Acute Myeloid Leukemia)   Alisertib 50 mg (Myelodysplastic Syndrome)
STARTED   46   11 
COMPLETED   0 [1]   0 
NOT COMPLETED   46   11 
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.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population was defined as all participants who received any amount of alisertib.

Reporting Groups
  Description
Alisertib 50 mg (Acute Myeloid Leukemia) 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).
Alisertib 50 mg (Myelodysplastic Syndrome) 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 Total of all reporting groups

Baseline Measures
   Alisertib 50 mg (Acute Myeloid Leukemia)   Alisertib 50 mg (Myelodysplastic Syndrome)   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   11   57 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   46   11   57 
   71.9  (7.41)   69.5  (12.50)   71.4  (8.54) 
Age, Customized 
[Units: Participants]
     
<60 years       
Participants Analyzed   46   11   57 
<60 years   4   2   6 
≥60 years       
Participants Analyzed   46   11   57 
≥60 years   42   9   51 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   46   11   57 
Female      22  47.8%      3  27.3%      25  43.9% 
Male      24  52.2%      8  72.7%      32  56.1% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino       
Participants Analyzed   46   11   57 
Hispanic or Latino   2   0   2 
Not Hispanic or Latino       
Participants Analyzed   46   11   57 
Not Hispanic or Latino   34   9   43 
Not Reported       
Participants Analyzed   46   11   57 
Not Reported   10   2   12 
Race/Ethnicity, Customized 
[Units: Participants]
     
White       
Participants Analyzed   46   11   57 
White   36   10   46 
Black or African American       
Participants Analyzed   46   11   57 
Black or African American   3   0   3 
Asian       
Participants Analyzed   46   11   57 
Asian   1   0   1 
Not Reported       
Participants Analyzed   46   11   57 
Not Reported   6   1   7 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed   46   11   57 
United States   33   9   42 
France       
Participants Analyzed   46   11   57 
France   11   2   13 
Canada       
Participants Analyzed   46   11   57 
Canada   2   0   2 
Height [1] 
[Units: Cm]
Mean (Standard Deviation)
     
Participants Analyzed   36   10   46 
   165.8  (8.35)   171.4  (9.98)   167.0  (8.93) 
[1] Baseline height data is available for n=36,10 participants, respectively.
Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
     
Participants Analyzed   45   11   56 
   73.7  (13.80)   80.4  (17.27)   75.0  (14.62) 
[1] Baseline weight data is available for n=45,11 participants, respectively.
Baseline Body Surface Area (BSA) [1] 
[Units: M^2]
Mean (Standard Deviation)
     
Participants Analyzed   36   10   46 
   1.83  (0.203)   1.94  (0.262)   1.86  (0.219) 
[1] Baseline BSA data is available for n=36,10 participants, respectively.
Years Since Initial Diagnosis 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   46   11   57 
   0.65  (0.793)   0.82  (0.780)   0.68  (0.787) 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
     
     
Participants Analyzed   46   11   57 
 9   3   12 
     
Participants Analyzed   46   11   57 
 29   8   37 
     
Participants Analyzed   46   11   57 
 8   0   8 
[1] 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.


  Outcome Measures

1.  Primary:   Best Overall Response Rate (ORR) Based on Investigator’s Assessment   [ 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) ]

2.  Secondary:   Progression Free Survival (PFS)   [ 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) ]

3.  Secondary:   Duration of Response (DOR)   [ 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) ]

4.  Secondary:   Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment   [ 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) ]

5.  Secondary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths   [ Time Frame: First dose of study drug to 30 days after last dose (Up to 18.9 months) ]

6.  Secondary:   Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events   [ Time Frame: First dose of study drug to 30 days after last dose (Up to 18.9 months) ]

7.  Secondary:   Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events   [ Time Frame: First dose of study drug to 30 days after last dose (Up to 18.9 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



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