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Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT01039207
Recruitment Status : Completed
First Posted : December 24, 2009
Results First Posted : September 7, 2017
Last Update Posted : September 7, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

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: Other: Laboratory Biomarker Analysis
Biological: Rilotumumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was opened to patient entry on October 10, 2010 and was closed to accrual on May 10, 2011.

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
AMG 102 AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)

Participant Flow:   Overall Study
    AMG 102
STARTED   31 
COMPLETED [1]   31 
NOT COMPLETED   0 
[1] Eligible and treated patients.



  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.
Eligible and treated patients.

Reporting Groups
  Description
AMG 102 AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)

Baseline Measures
   AMG 102 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age, Customized 
[Units: Participants]
 
40-49 years   4 
50-59 years   6 
60-69 years   9 
70-79 years   10 
80-89 years   2 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      31 100.0% 
Male      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4  12.9% 
White      27  87.1% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1   [ Time Frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years. ]

2.  Primary:   Progression-free Survival > 6 Months Using RECIST 1.0   [ Time Frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; up to 6 months. ]

3.  Secondary:   Incidence of Adverse Effects (Grade 3 or Higher) 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 ]

4.  Secondary:   Duration of Overall Survival (OS)   [ 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:   Duration of Progression-free Survival (PFS)   [ Time Frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years. ]

6.  Other Pre-specified:   Biomarker Panel From Tumor Tissue   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Circulating Levels of HGF/Scatter Factor (SF)   [ Time Frame: Up to 1 day prior to course 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Circulating Levels of Markers of Angiogenesis   [ Time Frame: Up to 1 day prior to course 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


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



Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01039207     History of Changes
Other Study ID Numbers: GOG-0170P
NCI-2011-01996 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000662115
20070612
GOG-0170P ( Other Identifier: NRG Oncology )
GOG-0170P ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 22, 2009
First Posted: December 24, 2009
Results First Submitted: August 8, 2017
Results First Posted: September 7, 2017
Last Update Posted: September 7, 2017