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Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01720173
First Posted: November 2, 2012
Last Update Posted: December 8, 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):
Gynecologic Oncology Group
Results First Submitted: August 3, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal 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
The study was activated on 11/5/2012 and closed to accrual on 10/2/2013.

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
Dalantercept

Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.

*Patients weighing more than 100kg will start treatment at 120mg, 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.


Participant Flow:   Overall Study
    Dalantercept
STARTED   30 
COMPLETED [1]   30 
NOT COMPLETED   0 
[1] Eligible and treated patients.



  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.
Eligible and treated patients

Reporting Groups
  Description
Dalantercept

Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.

*Patients weighing more than 100kg will start treatment at 120mg, 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.


Baseline Measures
   Dalantercept 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.0  (9.2) 
Age, Customized 
[Units: Participants]
Count of Participants
 
30-39 years   1 
40-49 years   6 
50-59 years   13 
60-69 years   5 
70-79 years   5 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      30 100.0% 
Male      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry   [ Time Frame: Every other cycle for first 6 months ]

2.  Primary:   Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up ]

3.  Primary:   Objective Tumor Response   [ Time Frame: Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years. ]

4.  Secondary:   Overall Survival   [ Time Frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. ]

5.  Secondary:   Progression-free Survival   [ Time Frame: Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years. ]

6.  Other Pre-specified:   Gene Expression Levels of ALK1 and Other Markers   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   IHC Expression Levels of VEGF, FGF, TGFB, ALK1, CD105 and Other Markers   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Pre-treatment Plasma Concentration Levels of VEGF, BMP9, BMP10, and ALK1   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: Angela Kuras on behalf of Wei Deng, PhD
Organization: NRG Oncology
phone: 716-845-5702
e-mail: kurasa@nrgoncology.org



Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01720173     History of Changes
Other Study ID Numbers: GOG-0170R
NCI-2012-01936 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NSC #757172
CDR0000742512
GOG-0170R ( Other Identifier: NRG Oncology )
GOG-0170R ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2012
First Posted: November 2, 2012
Results First Submitted: August 3, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017