The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,015
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
Progression free survival
Time frame: 3 years
Overall survival (OS)
Time frame: 5 years
Incidence of adverse events and significant laboratory abnormalities
Time frame: 4 years
Pharmacokinetics of AMG 386 (Cmax and Cmin)
pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7
Time frame: 1 year
Incidence of anti-AMG 386 antibody formation
pre-dose weeks 1, 10, 19
Time frame: 4 years
Patient reported ovarian cancer-specific symptoms and health related quality of life
Time frame: 4 years
Patient reported status as measured by the EuroQOL (EQ-5D)
Time frame: 4 years
AMG 386 exposure-response relationships for PFS and OS
Time frame: 4 years
Correlation of serum biomarkers with measures of response
Time frame: 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Research Site
Birmingham, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Anchorage, Alaska, United States
Research Site
Gilbert, Arizona, United States
Research Site
Peoria, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Berkeley, California, United States
...and 300 more locations