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Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01553539
First received: March 9, 2012
Last updated: December 10, 2013
Last verified: December 2013
Results First Received: November 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bone Cancer
Chondrosarcoma
Clear Cell Sarcoma of the Kidney
Metastatic Osteosarcoma
Ovarian Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Osteosarcoma
Recurrent Uterine Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage III Uterine Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage IV Uterine Sarcoma
Interventions: Drug: therapeutic angiotensin-(1-7)
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
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
Treatment (Antiangiogenesis Therapy) Patients receive therapeutic angiotensin-(1-7) subcutaneous (SC) once daily in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Antiangiogenesis Therapy)  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     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
Treatment (Antiangiogenesis Therapy) Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Treatment (Antiangiogenesis Therapy)  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     18  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  51.4  ± 14.9  
Gender  
[units: participants]
 
Female     9  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response   [ Time Frame: Approximately 1 year ]

2.  Primary:   Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0   [ Time Frame: Approximately 1 year ]

3.  Secondary:   Time to Disease Progression   [ Time Frame: Approximately 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Overall Survival   [ Time Frame: Approximately 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)   [ Time Frame: Day 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Plasma Levels of Angiogenic Peptides Including PIGF   [ Time Frame: Day 22 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. William J. Petty
Organization: Wake Forest University Health Sciences
phone: 336-716-3313
e-mail: wpetty@wakehealth.edu


No publications provided


Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01553539     History of Changes
Obsolete Identifiers: NCT00974545
Other Study ID Numbers: CCCWFU 71108, NCI-2009-01259, 003936-01A2
Study First Received: March 9, 2012
Results First Received: November 15, 2013
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration