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-GR
• Date of registration: 21/11/2011
• 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: 09/01/2012
• 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, 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 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: 14.0 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 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: AMG 386
CAS Number: N/A
Current Sponsor code: AMG 386
Other descriptive name: AMG 386
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)

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

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

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)

Secondary Outcome(s)

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

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 ID(s)

20101129

Source(s) of Monetary Support

Amgen Inc.