Completed
PHASE2
INTERVENTIONAL
NCT00719212
Study of AMG 479 as Second Line Therapy in Patients With Recurrent Platinum-sensitive Ovarian Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study is to obtain an estimate of the objective response rate (ORR) of AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma failing frontline chemotherapy.
Interventions
Name:
AMG 479
Type:
BIOLOGICAL
Description:
Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle
Primary Outcomes
Measure:
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
TimeFrame:
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
Description:
RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions \& normalization of tumor marker level/ā¢PR:at least 30% decrease in the sum of the longest diam(LD) of target lesĀ° taking as ref the baseline sum LD OR CR for target lesĀ° \& incomplete response/SD for nontarget lesĀ°.
CR \& PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:
* PR:elevated CA125 at baseline PR considered if a ā„ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart
* CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST \& CA125 /-PR: if CR as per RECIST \& PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST \& CR/PR or SD as per CA125
Measure:
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.
TimeFrame:
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
Description:
RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions \& normalization of tumor marker level/ā¢PR:at least 30% decrease in the sum of the longest diam(LD) of target lesĀ° taking as ref the baseline sum LD OR CR for target lesĀ° \& incomplete response/SD for nontarget lesĀ°.
CR \& PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:
* PR:elevated CA125 at baseline PR considered if a ā„ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart
* CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST \& CA125 /-PR: if CR as per RECIST \& PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST \& CR/PR or SD as per CA125
Trial Information
NCT ID
NCT00719212
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Translational Research in Oncology
Last Updated
December 15, 2025