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

• Register: EUCTR
• Last refreshed on: 6 February 2017
• Main ID: EUCTR2011-001112-53-BE
• Date of registration: 29/11/2011
• Prospective Registration: Yes
• 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: 30/01/2012
• Target sample size: 1000
• 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, European Union, Germany, Greece, Hong Kong, Italy, Japan, Korea, Republic of, Netherlands, Russian Federation, Spain, United States

Contacts

• Name: IHQ Medical Info - Clinical trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info - Clinical trials
• Affiliation: Amgen (EUROPE) GmbH

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 708
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 313

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

FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
MedDRA version: 17.0 Level: PT Classification code 10061269 Term: Malignant peritoneal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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

Intervention(s)

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 386
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

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 386
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical form of the placebo: Powder for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Secondary Objective: To evaluate the effect of AMG 386 plus paclitaxel and carboplatin
compared to paclitaxel and carboplatin on overall survival (OS)

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.

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

Timepoint(s) of evaluation of this end point: Interim analysis – 307 PFS events (28 months post FSE)
Primary analysis – 613 PFS events (42 months post FSE)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Interim Analysis - efficacy only and at same time as PFS Primary Analysis - (613 PFS events, 42 months post FSE)
Primary Analysis - 500 OS events (60-62 months after FSE)
Additional Analysis - 700 OS events (approximately 8 years after FSE)

Secondary end point(s): Overall Survival (OS)
The primary analysis of OS will be conducted when a total of 500 OS events have been observed. The interim analysis of OS is for efficacy only and will be conducted at the same time as the primary analysis of PFS.
It is anticipated that 500 deaths will have occurred 60 to 62 months after the first subject is enrolled. An additional analysis of survival will occur after 700 deaths have been observed. This analysis will be noninferential and is anticipated to occur approximately 8 years after the first subject is randomized.

Secondary ID(s)

20101129

2011-001112-53-GR

Source(s) of Monetary Support

Amgen Inc.