To estimate the treatment effect and safety of AMG 386 in combination with paclitaxel + carboplatin in subjects with FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers.
ID
Source
Brief title
Condition
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression free survival
Secondary outcome
Overall survival
Background summary
In this study, the study medication AMG 386 is evaluated for the treatment of
patients with FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or
Fallopian Tube Cancers. AMG 386 is a man-made medication that is designed to
stop the development of blood vessels in cancer tissues. Cancer tissues rely on
the development of new blood vessels, a process called angiogenesis, to obtain
a supply of oxygen and nutrients to grow. AMG 386 is considered experimental
(or investigational). AMG 386 is not approved by any regulatory organization
(such as the Food and Drug Administration, FDA) to treat any type of cancer.
AMG 386 will be evaluated in this study in combination with paclitaxel and
carboplatin.
About 1000 patients will participate in this study from regions including the
Unites States and Europe. Amgen Inc. a for-profit drug company, is funding this
clinical study.
Study objective
To estimate the treatment effect and safety of AMG 386 in combination with
paclitaxel + carboplatin in subjects with FIGO Stage III-IV Epithelial Ovarian,
Primary Peritoneal or Fallopian Tube Cancers.
Study design
This is a multicentre, randomized, phase 3 study. The study consists of 3 of
parts. The first part is the screening. If the patient is eligible for the
study, she will go into the treatment phase and this phase lasts until the
patients had 18 months treatment during the maintenance phase.
After completion of the treatment, the patient will be followed by the study
staff by telephone or at clinic visits approximately every 3 months for up to 6
years after the last subject started with the study.
Each subject participating in this clinical research study will receive 1 of
the following treatments:
Arm A: AMG 386 with Paclitaxel and Carboplatin
Arm B: Placebo with Paclitaxel and Carboplatin
Intervention
Subjects will receive besided blinded AMG386 or placebo (QW, 18 weeks treatment
phase and 18 months maintanance phase), paclitaxel (Q3W, 6 cycles) and
carboplatin (Q3W, 6 cycles).
Study burden and risks
Risk:
Adverse effects of study medication AMG386. During the visits to the hospital
the subjects will be monitored for adverse events
Burden:
Maximum study duration is about 102 months. The subject will visit the hospital
every week. The duration of each visit will vary from 1 to 6 hours.
Minervum 7061
Breda 4817 ZK
NL
Minervum 7061
Breda 4817 ZK
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-001112-53-NL |
| ClinicalTrials.gov | NCT01493505 |
| CCMO | NL38125.058.11 |