To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancers. The hypothesis is that AMG 386 in combination with carboplatin and paclitaxel is safe and well tolerated.
To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancers. The hypothesis is that AMG 386 in combination with carboplatin and paclitaxel is safe and well tolerated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
15 mg/Kg AMG 386 IV (intravenous) weekly plus paclitaxel and carboplatin IV Q3W for 18 weeks, followed by 15mg/Kg AMG 386 IV (intravenous) weekly alone for an additional 18 months.
Research Site
Footscray, Victoria, Australia
Research Site
Malvern, Victoria, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Brussels, Belgium
To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancers.
Time frame: 18 weeks of combination therapy
To evaluate the pharmacokinetics (Cmax, AUC and Cmin) of AMG 386 in combination with carboplatin and paclitaxel
Time frame: Week 1 until Week 7
To estimate the incidence of anti-AMG 386 antibody formation
Time frame: Week 1 until maximum of 1 year following first dose
To evaluate the objective response rate (ORR) among subjects receiving AMG 386 in combination with carboplatin and paclitaxel
Time frame: From date of first dose until the subject reaches End of Study. This will continue until 36 months after the last subject has been enrolled.
To evaluate the duration of response (DOR) among subjects receiving AMG 386 in combination with carboplatin and paclitaxel
Time frame: From date of first dose until the subject reaches End of Study. This will continue until 36 months after the last subject has been enrolled.
To evaluate progression-free survival (PFS) among subjects receiving AMG 386 in combination with carboplatin and paclitaxel
Time frame: From date of first dose until the subject reaches End of Study. This will continue until 36 months after the last subject has been enrolled.
To evaluate the number of participants with adverse events and clinical laboratory abnormalities
Time frame: 96 weeks
To evaluate the effect of AMG 386 on the pharmacokinetics (Cmax, AUC and Cmin) of carboplatin and paclitaxel
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Research Site
Brussels, Belgium
Research Site
Leuven, Belgium
Research Site
Barcelona, Catalonia, Spain
Research Site
Madrid, Madrid, Spain
Time frame: Week 1 until Week 7