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Trial record 1 of 1 for:    A091102
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Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01653028
First received: July 26, 2012
Last updated: November 1, 2016
Last verified: November 2016
Results First Received: August 22, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Myxofibrosarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Leiomyosarcoma
Recurrent Liposarcoma
Recurrent Malignant Peripheral Nerve Sheath Tumor
Recurrent Undifferentiated Pleomorphic Sarcoma
Stage III Soft Tissue Sarcoma
Stage IV Soft Tissue Sarcoma
Interventions: Drug: Alisertib
Other: Laboratory Biomarker Analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From August 2012 to April 2014, a total of 72 patients were accrued to this study (Cohort 1 – 12, Cohort 2 – 10, Cohort 3 – 11, Cohort 4 – 10 Cohort 5 – 29) at a rate of 4.5 patients per month.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort 1 Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort 2 Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort 3 Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort4 Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort 5 Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Cohort 1   Cohort 2   Cohort 3   Cohort4   Cohort 5
STARTED   12   10   11   10   29 
COMPLETED   12   10   11   10   29 
NOT COMPLETED   0   0   0   0   0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Cohort 1 Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort 2 Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort 3 Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort4 Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohort 5 Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Cohort 1   Cohort 2   Cohort 3   Cohort4   Cohort 5   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   10   11   10   29   72 
Age 
[Units: Years]
Median (Full Range)
 61 
 (40 to 72) 
 56.5 
 (39 to 84) 
 66 
 (49 to 76) 
 52.5 
 (29 to 71) 
 49 
 (20 to 83) 
 54.5 
 (20 to 84) 
Gender 
[Units: Participants]
Count of Participants
           
Female      7  58.3%      3  30.0%      5  45.5%      4  40.0%      14  48.3%      33  45.8% 
Male      5  41.7%      7  70.0%      6  54.5%      6  60.0%      15  51.7%      39  54.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   3.4%      1   1.4% 
Asian      2  16.7%      0   0.0%      0   0.0%      1  10.0%      0   0.0%      3   4.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      2  18.2%      2  20.0%      2   6.9%      6   8.3% 
White      10  83.3%      10 100.0%      9  81.8%      7  70.0%      25  86.2%      61  84.7% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   3.4%      1   1.4% 
Region of Enrollment 
[Units: Participants]
           
United States   12   10   11   10   29   72 


  Outcome Measures
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1.  Primary:   The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.   [ Time Frame: Up to 18 months ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: The time between registration and death, assessed up to 18 months ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: The time between registration to disease progression or death, assessed up to 18 months ]

4.  Secondary:   Adverse Events   [ Time Frame: During treatment and up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark Andrew Dickson M.D.
Organization: Memorial Sloan Kettering Cancer Center
phone: 6468884164
e-mail: dicksonm@mskcc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01653028     History of Changes
Other Study ID Numbers: NCI-2012-01991
NCI-2012-01991 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000737403
CALGB-A091102
A091102 ( Other Identifier: Alliance for Clinical Trials in Oncology )
A091102 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
Study First Received: July 26, 2012
Results First Received: August 22, 2016
Last Updated: November 1, 2016