Brief Summary
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.
Brief Title
TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
Categories
Completion Date
Completion Date Type
Actual
Conditions
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Eligibility Criteria
Inclusion Criteria:
* Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
* Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
* Subjects with FIGO Stage IIIC or IV disease must either:
* Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
* Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
* ECOG performance status of 0 or 1
* Adequate bone marrow, renal and hepatic function
Exclusion Criteria:
* Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
* Previous abdominal and/or pelvic external beam radiotherapy
* History of central nervous metastasis
* History of arterial or venous thromboembolism within 12 months prior to randomization
* Clinically significant cardiovascular disease within 12 months prior to randomization
* Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
* Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
* Subjects with FIGO Stage IIIC or IV disease must either:
* Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
* Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
* ECOG performance status of 0 or 1
* Adequate bone marrow, renal and hepatic function
Exclusion Criteria:
* Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
* Previous abdominal and/or pelvic external beam radiotherapy
* History of central nervous metastasis
* History of arterial or venous thromboembolism within 12 months prior to randomization
* Clinically significant cardiovascular disease within 12 months prior to randomization
Inclusion Criteria
Inclusion Criteria:
* Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
* Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
* Subjects with FIGO Stage IIIC or IV disease must either:
* Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
* Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
* ECOG performance status of 0 or 1
* Adequate bone marrow, renal and hepatic function
* Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
* Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
* Subjects with FIGO Stage IIIC or IV disease must either:
* Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
* Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
* ECOG performance status of 0 or 1
* Adequate bone marrow, renal and hepatic function
Gender
Female
Gender Based
false
Keywords
Primary Peritoneal Cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01493505
Org Class
Industry
Org Full Name
Amgen
Org Study Id
20101129
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
Primary Outcomes
Outcome Measure
Progression free survival
Outcome Time Frame
3 years
Secondary Ids
Secondary Id
TRINOVA-3 20101129/ENGOT-ov2
Secondary Outcomes
Outcome Time Frame
5 years
Outcome Measure
Overall survival (OS)
Outcome Time Frame
4 years
Outcome Measure
Incidence of adverse events and significant laboratory abnormalities
Outcome Description
pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7
Outcome Time Frame
1 year
Outcome Measure
Pharmacokinetics of AMG 386 (Cmax and Cmin)
Outcome Description
pre-dose weeks 1, 10, 19
Outcome Time Frame
4 years
Outcome Measure
Incidence of anti-AMG 386 antibody formation
Outcome Time Frame
4 years
Outcome Measure
Patient reported ovarian cancer-specific symptoms and health related quality of life
Outcome Time Frame
4 years
Outcome Measure
Patient reported status as measured by the EuroQOL (EQ-5D)
Outcome Time Frame
4 years
Outcome Measure
AMG 386 exposure-response relationships for PFS and OS
Outcome Time Frame
4 years
Outcome Measure
Correlation of serum biomarkers with measures of response
See Also Links
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mark Einstein
Investigator Email
meinstei@montefiore.org
Investigator Phone