A study of AMG 386 or placebo in combination with paclitaxel and carboplatin to treat ovarian cancer

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2011-001112-53-IT
• Date of registration: 02/03/2012
• Prospective Registration: No
• Primary sponsor: AMGEN INC.
• Public title: A study of AMG 386 or placebo in combination with paclitaxel and carboplatin to treat ovarian cancer
• Scientific 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
• Date of first enrolment: 19/01/2012
• Target sample size: 2000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001112-53
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Canada, Denmark, Germany, Greece, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Korea, Republic of, Netherlands, Russian Federation, Spain, United States

Contacts

• Name: Dipartimento Regolatorio
• Affiliation: Amgen Dompe' SpA

• Name: Dipartimento Regolatorio
• Affiliation: Amgen Dompe' SpA

Key inclusion & exclusion 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: 0
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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
MedDRA version: 14.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Name: AMG 386
Product Code: AMG 386
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: AMG 386
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 150-600
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

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 progressionfree
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 IIIIV
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.

Primary end point(s): PFS - Pogression Free Survival

Secondary Outcome(s)

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)
• 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

Secondary ID(s)

20101129

2011-001112-53-GR

Source(s) of Monetary Support

Amgen Inc.