Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01642082
First received: July 15, 2012
Last updated: January 7, 2016
Last verified: January 2016
Results First Received: January 7, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Endometrial Adenocarcinoma
Endometrial Adenosquamous Carcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Recurrent Uterine Corpus Carcinoma
Interventions: Biological: Dalantercept
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
All patients underwent disease evaluation with baseline CT of the chest, abdomen and pelvis. After obtaining informed consent and verification of eligibility, patients were enrolled and treatment initiated.

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
Dalantercept

Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.

Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.

A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy.


Participant Flow:   Overall Study
    Dalantercept  
STARTED     28  
COMPLETED     28  
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.
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Reporting Groups
  Description
Treatment (Dalantercept)

Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Dalantercept: Given SC

Laboratory Biomarker Analysis: Correlative studies


Baseline Measures
    Treatment (Dalantercept)  
Number of Participants  
[units: participants]
  28  
Age, Customized  
[units: participants]
 
40-49     1  
50-59     9  
60-69     13  
70-79     5  
Gender  
[units: participants]
 
Female     28  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     28  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response   [ Time Frame: Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. Responses must be confirmed. ]

2.  Primary:   Treatment and Progression-free Survival at 6 Months   [ Time Frame: CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease ]

3.  Secondary:   Progression-free Survival at 6 Months   [ Time Frame: : CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. ]

4.  Secondary:   Duration of Progression-free Survival   [ Time Frame: CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. ]

5.  Secondary:   Duration of Survival   [ Time Frame: Patients are followed every three months for the first two years and then every six months for the next three years. ]

6.  Secondary:   Adverse Events (Primary Serious and All Other AEs)   [ Time Frame: Every cycle of study treatment and after treatment for a maximum of 5 years from study entry ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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 NOT 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.


Results Point of Contact:  
Name/Title: Linda Gedeon, BA, CCRP Clinical Research Coordinator
Organization: NRG Oncology
phone: 716-845-1169
e-mail: lgedeon@gogstats.org



Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01642082     History of Changes
Other Study ID Numbers: GOG-0229N
NCI-2012-01986 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000736764
GOG-0229N ( Other Identifier: Gynecologic Oncology Group )
GOG-0229N ( Other Identifier: CTEP )
U10CA027469 ( US NIH Grant/Contract Award Number )
Study First Received: July 15, 2012
Results First Received: January 7, 2016
Last Updated: January 7, 2016
Health Authority: United States: Food and Drug Administration