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Study of AMG 479 as Second Line Therapy in Patients With Recurrent Platinum-sensitive Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Translational Research in Oncology
ClinicalTrials.gov Identifier:
NCT00719212
First received: July 18, 2008
Last updated: December 8, 2015
Last verified: December 2015
Results First Received: October 22, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Neoplasms
Intervention: Biological: AMG 479

  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 conducted over a total of 35 sites in 7 countries.

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 479

AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.

AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle


Participant Flow:   Overall Study
    AMG 479
STARTED   61 
COMPLETED   17 
NOT COMPLETED   44 
Death                41 
Lost to Follow-up                2 
Withdrawal by Subject                1 



  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
AMG 479

AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.

AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle


Baseline Measures
   AMG 479 
Overall Participants Analyzed 
[Units: Participants]
 61 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   39 
>=65 years   22 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.8  (10.4) 
Gender 
[Units: Participants]
 
Female   61 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   18 
Canada   7 
Germany   4 
France   24 
Ireland   7 
Israel   1 
Eastern Cooperative Oncology Group Performance Status (ECOG PS) [1] 
[Units: Participants]
 
PS 0 (fully active)   41 
PS 1 (restricted in physically strenuous activity)   20 
[1] 6-point (0 to 5) ordinal scale to assess how the disease affects the daily living abilities of the patient and determine apporpriate treatment and prognosis
Time from initial diagnosis to registration 
[Units: Months]
Mean (Standard Deviation)
 20.4  (6.2) 
Origin of tumor 
[Units: Participants]
 
Primary Peritoneal   5 
Fallopian Tube   3 
Ovarian   46 
Ovarian + Primary Peritoneal   3 
Ovarian + Fallopian Tube   4 
Stage at First Diagnosis (International Federation of Gynecology and Obstetrics (FIGO) ) [1] 
[Units: Participants]
 
IC   3 
IIA   1 
IIB   2 
IIC   2 
IIIA   1 
IIIB   3 
IIIC   44 
IV   5 
[1] 5-point ordinal scale to assess the extent of the disease (0 ->IV). Roman numeral staging from the less to the most advanced cancer. Individual stage (I to III) is broken down in substage: IA, IB, IC,...
Histopathologic Type 
[Units: Participants]
 
Papillary serous   42 
Mucinous   2 
Endometroid   5 
Clear cell   4 
Mixed   2 
Other   6 
Histologic Grade (G) [1] 
[Units: Participants]
 
G1 (well differentiated)   1 
G2 (moderately differentiated)   6 
G3 (poorly differentiated)   45 
Not done   9 
[1] Cancer cells compared with normal cells
CA 125 status [1] 
[Units: Participants]
 
With elevated CA 125 only   5 
With elevated CA 125 + Non target lesion(s) only   11 
With elevatCA125+target lesions+/-nontargetlesions   37 
With CA125normal+target lesions+/-nontargetlesions   8 
[1] CA 125 level measurement from a blood sample
Number of prior therapies [1] 
[Units: Participants]
 
1 therapy   2 
2 therapies   38 
3 therapies   16 
4 therapies   3 
5 therapies   2 
[1] Prior anti-tumor treatment characteristics


  Outcome Measures
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1.  Primary:   Objective Response Rate (ORR) Investigator Assessment: % of Patients in the Group Who Achieve a Complete Response(CR) or Partial Response(PR) According to RECIST Criteria and GCIG CA125 Response Criteria. - Assessments of the Response by the Investigators   [ Time Frame: Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle ]

2.  Primary:   Objective Response Rate (ORR) Independent Radiology Committee % of Patients in the Group Who Achieve a Complete or Partial Response According to RECIST Criteria and GCIG CA 125 Response Criteria.   [ Time Frame: Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle ]

3.  Secondary:   Time To Progression (TTP) Investigator Assessment   [ Time Frame: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response ]

4.  Secondary:   Clinical Benefit Rate (CBR) Investigator Assessmt % of Patients in the gp Who Achieve a Complete Response-CR,Partial Response-PR or Stable Disease-SD for 16wks From Registrat° Considering the Global Response Combining RECIST Criteria and CA125 Assessmts   [ Time Frame: At 16 weeks from registration ]

5.  Secondary:   Overall Survival (OS) Investigator Assessment   [ Time Frame: Day 1 of each cycle during study treatment + follow-up every 6 months for the first 3 years in the study or until death whichever occurs first ]

6.  Secondary:   Time To Marker Progression (TTMP) Investigator Assessment - Interval Form the Date of Registration to the Date of Disease Progression as Per GCIG 2005 Definition of CA 125 Progression.   [ Time Frame: Day 1 of each cycle ]

7.  Secondary:   Progression-free Survival (PFS) Investigator Assessment - Interval From Registration to Disease Progression or Death Due to Any Cause - According to RECIST and CA 125   [ Time Frame: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response ]


  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: Matthieu Rupin
Organization: Translational Research In Oncology (formerly CIRG)
phone: +33 (1) 58 10 08 89
e-mail: matthieu.rupin@trioncology.org



Responsible Party: Translational Research in Oncology
ClinicalTrials.gov Identifier: NCT00719212     History of Changes
Other Study ID Numbers: TRIO 015
Study First Received: July 18, 2008
Results First Received: October 22, 2015
Last Updated: December 8, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Ireland: Health Products Regulatory Authority
Israel: Israeli Health Ministry Pharmaceutical Administration