FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers MedDRA version: 14.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classification code 10061269 Term: Malignant peritoneal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classifi
Conditions
Interventions
Product Name: AMG 386
Product Code: AMG 386
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: AMG 386
CAS Number: N/A
Current Sponsor code: AMG 386
Other descriptive name: AMG
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
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 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 os 0 or 1 Adequate bone marrow, renal and hepatic funtion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 600
Exclusion criteria
Exclusion criteria: Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers Previous abdonimal 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Interim analysis – 477 OS events (33 months post FSE) Primary analysis – 900 OS events (54 months post FSE ;Secondary end point(s): • Overall Survival (OS) OS is defined as the time from the randomization date to the date of death from any cause. Subjects who have been lost to follow-up before the analysis data cutoff date or otherwise have not died by the analysis data cutoff date will be censored at their last contact date (last known to be alive) • Incidence of adverse events and significant laboratory abnormalities • Pharmacokinetics of AMG 386 (Cmax and Cmin) • Incidence of anti-AMG 386 antibody formation • Patient reported ovarian cancer-specific symptoms and health related quality of life • Patient reported health status as measured by the EQ-5D • AMG 386 exposure-response relationships for PFS and OS • Correlation of serum biomarkers with measures of response | — |
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Pogression Free Survival (PFS) PFS is defined as the time from the randomization date to the earlier of the dates of (1) the first objective disease progression per RECIST 1.1 with modifications (see protocol for details) or (2) death from any cause.;Timepoint(s) of evaluation of this end point: Interim analysis – 438 PFS events (21 months post FSE) Primary analysis – 719 PFS events (3 months post completion of accrual) ;Main Objective: To determine if 6 cycles of paclitaxel and carboplatin plus AMG 386 followed by 18 months of AMG 386 maintenance improves progression-free survival (PFS) compared to 6 cycles of paclitaxel and carboplatin plus AMG 386 placebo followed by 18 months of AMG 386 placebo maintenance in the first-line treatment of subjects with FIGO Stage III-IV epithelial ovarian, primary peritoneal or fallopian tube cancers;Secondary Objective: To determine if 6 cycles of paclitaxel and carboplatin plus AMG 386 followed by 18 months of AMG 386 maintenance improves overall survival (OS) compared to 6 cycles of paclitaxel and carboplatin plus AMG 386 placebo followed by 18 months of AMG 386 placebo maintenance To evaluate the safety and tolerability of AMG 386 plus paclitaxel and carboplatin To evaluate the pharmacokinetics (PK) of AMG 386 (Cmax and Cmin) To estimate the incidence of anti-AMG 386 antibody formation To estimate the effect of AMG 386 on patient reported ovarian cancer-specific symptoms and overall health status as measured by the EuroQOL (EQ-5D) questionnaire. Due to exceeding size the rest can be found in the protocol | — |
Countries
Austria, Belgium, Canada, Denmark, European Union, Germany, Greece, Hong Kong, Italy, Japan, Korea, Republic of, Netherlands, Russian Federation, Spain, United States
Contacts
Public ContactIHQ Medical Info - Clinical trials
Amgen (EUROPE) GmbH
Outcome results
None listed