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Trial record 10 of 20 for:    "dermatofibrosarcoma protuberans"

AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00659360
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : July 30, 2015
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Fibrosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Adult Malignant Fibrous Histiocytoma
Adult Rhabdomyosarcoma
Dermatofibrosarcoma Protuberans
Endometrial Stromal Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Uterine Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage III Uterine Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage IV Uterine Sarcoma
Uterine Carcinosarcoma
Uterine Leiomyosarcoma
Intervention: Drug: saracatinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm I AZD0530

Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally


Participant Flow:   Overall Study
    Arm I AZD0530
STARTED   17 
COMPLETED   17 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
Arm I

Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally


Baseline Measures
   Arm I 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Years]
Median (Full Range)
 65 
 (22 to 79) 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8  47.1% 
>=65 years      9  52.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  64.7% 
Male      6  35.3% 
Region of Enrollment 
[Units: Participants]
 
United States   8 
Canada   9 


  Outcome Measures

1.  Primary:   Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months.   [ Time Frame: Up to 5 years ]

2.  Secondary:   Objective Response Rate   [ Time Frame: Up to 5 years ]

3.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]

4.  Secondary:   Stable Disease Rate   [ Time Frame: Up to 5 years ]

5.  Secondary:   Duration of Response   [ Time Frame: Up to 5 years ]

6.  Secondary:   Time to Disease Progression   [ Time Frame: Up to 5 years ]


  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
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  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 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: Dr. Margaret Von Mehren
Organization: Cross Cancer Institute
phone: 215-214-1663
e-mail: margaret.vonmehren@fccc.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00659360     History of Changes
Other Study ID Numbers: NCI-2009-01054
PHL-054 ( Other Grant/Funding Number: N01CM62203 )
CDR0000588034 ( Other Grant/Funding Number: N01CM62203 )
PMH-PHL-054 ( Other Grant/Funding Number: N01CM62203 )
N01CM62203 ( U.S. NIH Grant/Contract )
First Submitted: April 15, 2008
First Posted: April 16, 2008
Results First Submitted: June 19, 2014
Results First Posted: July 30, 2015
Last Update Posted: June 29, 2018