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Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154816
First Posted: July 1, 2010
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
Results First Submitted: July 28, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hepatoblastoma
Previously Treated Childhood Rhabdomyosarcoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Kidney Neoplasm
Recurrent Childhood Malignant Germ Cell Tumor
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Soft Tissue Sarcoma
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Recurrent Neuroblastoma
Recurrent Osteosarcoma
Interventions: Drug: Alisertib
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Recurrent Neuroblastoma With Measurable Disease at Enrollment Experimental: Arm 1
Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll Experimental: Arm 2
Previously Treated Childhood Rhabdomyosarcoma Experimental: Arm 3
Recurrent Osteosarcoma Experimental: Arm 4
Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor Experimental: Arm 5
Recurrent Childhood Soft Tissue Sarcoma Experimental: Arm 6
Childhood Hepatoblastoma Experimental: Arm 7
Recurrent Childhood Germ Cell Tumor Experimental: Arm 8
Recurrent Wilms Tumor and Other Childhood Kidney Tumors Experimental: Arm 9
Recurrent Childhood Acute Lympohblastic Leukemia Experimental: Arm 10
Recurrent Childhood Acute Myeloid Leukemia Experimental: Arm 11
Rhaboid Malignancy Experimental: Arm 12

Participant Flow:   Overall Study
    Recurrent Neuroblastoma With Measurable Disease at Enrollment   Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll   Previously Treated Childhood Rhabdomyosarcoma   Recurrent Osteosarcoma   Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor   Recurrent Childhood Soft Tissue Sarcoma   Childhood Hepatoblastoma   Recurrent Childhood Germ Cell Tumor   Recurrent Wilms Tumor and Other Childhood Kidney Tumors   Recurrent Childhood Acute Lympohblastic Leukemia   Recurrent Childhood Acute Myeloid Leukemia   Rhaboid Malignancy
STARTED   20   12   10   10   10   8   6   7   10   10   11   4 
COMPLETED   0   2   0   0   0   0   0   0   1   0   0   0 
NOT COMPLETED   20   10   10   10   10   8   6   7   9   10   11   4 
Withdrawal by Subject                1                0                0                1                0                0                0                0                1                3                0                0 
Progressive Disease                13                8                9                9                8                8                5                6                8                6                10                3 
Physician Decision                1                0                1                0                2                0                0                0                0                1                1                1 
Adverse Event                5                2                0                0                0                0                1                1                0                0                0                0 



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Recurrent Neuroblastoma With Measurable Disease at Enrollment Experimental: Arm 1
Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll Experimental: Arm 2
Previously Treated Childhood Rhabdomyosarcoma Experimental: Arm 3
Recurrent Osteosarcoma Experimental: Arm 4
Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor Experimental: Arm 5
Recurrent Childhood Soft Tissue Sarcoma Experimental: Arm 6
Childhood Hepatoblastoma Experimental: Arm 7
Recurrent Childhood Germ Cell Tumor Experimental: Arm 8
Recurrent Wilms Tumor and Other Childhood Kidney Tumors Experimental: Arm 9
Recurrent Childhood Acute Lympohblastic Leukemia Experimental: Arm 10
Recurrent Childhood Acute Myeloid Leukemia Experimental: Arm 11
Rhaboid Malignancy Experimental: Arm 12
Total Total of all reporting groups

Baseline Measures
   Recurrent Neuroblastoma With Measurable Disease at Enrollment   Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll   Previously Treated Childhood Rhabdomyosarcoma   Recurrent Osteosarcoma   Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor   Recurrent Childhood Soft Tissue Sarcoma   Childhood Hepatoblastoma   Recurrent Childhood Germ Cell Tumor   Recurrent Wilms Tumor and Other Childhood Kidney Tumors   Recurrent Childhood Acute Lympohblastic Leukemia   Recurrent Childhood Acute Myeloid Leukemia   Rhaboid Malignancy   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   12   10   10   10   8   6   7   10   10   11   4   118 
Age 
[Units: Years]
Median (Full Range)
 8 
 (3 to 20) 
 8 
 (5 to 17) 
 12 
 (4 to 21) 
 17 
 (12 to 21) 
 14 
 (6 to 20) 
 16 
 (13 to 21) 
 5 
 (3 to 14) 
 11 
 (3 to 19) 
 10 
 (3 to 18) 
 13 
 (7 to 19) 
 10 
 (3 to 15) 
 5 
 (2 to 7) 
 11 
 (2 to 21) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                         
Female      10  50.0%      2  16.7%      7  70.0%      3  30.0%      3  30.0%      4  50.0%      1  16.7%      4  57.1%      7  70.0%      3  30.0%      6  54.5%      2  50.0%      52  44.1% 
Male      10  50.0%      10  83.3%      3  30.0%      7  70.0%      7  70.0%      4  50.0%      5  83.3%      3  42.9%      3  30.0%      7  70.0%      5  45.5%      2  50.0%      66  55.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
                         
Hispanic or Latino      3  15.0%      1   8.3%      1  10.0%      3  30.0%      1  10.0%      2  25.0%      3  50.0%      2  28.6%      4  40.0%      2  20.0%      4  36.4%      1  25.0%      27  22.9% 
Not Hispanic or Latino      15  75.0%      10  83.3%      7  70.0%      7  70.0%      8  80.0%      5  62.5%      3  50.0%      4  57.1%      5  50.0%      8  80.0%      5  45.5%      3  75.0%      80  67.8% 
Unknown or Not Reported      2  10.0%      1   8.3%      2  20.0%      0   0.0%      1  10.0%      1  12.5%      0   0.0%      1  14.3%      1  10.0%      0   0.0%      2  18.2%      0   0.0%      11   9.3% 
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%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  10.0%      1   8.3%      1  10.0%      2  20.0%      0   0.0%      1  12.5%      1  16.7%      0   0.0%      2  20.0%      2  20.0%      2  18.2%      0   0.0%      14  11.9% 
White      15  75.0%      7  58.3%      7  70.0%      7  70.0%      8  80.0%      3  37.5%      3  50.0%      4  57.1%      5  50.0%      5  50.0%      2  18.2%      3  75.0%      69  58.5% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      3  15.0%      4  33.3%      2  20.0%      1  10.0%      2  20.0%      4  50.0%      2  33.3%      3  42.9%      3  30.0%      3  30.0%      7  63.6%      1  25.0%      35  29.7% 
Region of Enrollment [1] 
[Units: Participants]
                         
Canada   1   2   1   0   0   0   1   1   1   0   1   0   8 
United States   18   9   9   10   10   8   5   6   8   10   10   4   107 
United Kingdom   1   1   0   0   0   0   0   0   0   0   0   0   2 
[1] Region unknown for 1 patient in the Recurrent Wilms Tumor and Other Childhood Kidney Tumors arm.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Frequency of RECIST Response   [ Time Frame: From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first. ]

2.  Secondary:   Number of Patients Cycles With Grade 3 or Higher Adverse Event   [ Time Frame: Up to 24 months ]

3.  Secondary:   Serum Concentration of Alisertib Prior to the First Day of Administration   [ Time Frame: day 1 of protocol therapy ]

4.  Secondary:   Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration   [ Time Frame: day 1 of protocol therapy ]

5.  Secondary:   Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration   [ Time Frame: day 1 of protocol therapy ]

6.  Secondary:   Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration   [ Time Frame: day 1 of protocol therapy ]

7.  Secondary:   Serum Concentration of Alisertib on the Fourth Day of Administration Prior to the Administration of the Day 4 Dose   [ Time Frame: day 4 of protocol therapy ]

8.  Secondary:   Serum Concentration of Alisertib on the Seventh Day of Administration Prior to the Administration of the Day 7 Dose.   [ Time Frame: day 7 of protocol therapy ]


  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
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  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 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: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01154816     History of Changes
Other Study ID Numbers: ADVL0921
NCI-2011-02051 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000680512
ADVL0921 ( Other Identifier: Childrens Oncology Group )
ADVL0921 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: June 30, 2010
First Posted: July 1, 2010
Results First Submitted: July 28, 2016
Results First Posted: June 5, 2017
Last Update Posted: September 13, 2017



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