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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer

Thank you

Trial Information

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


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 an 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 of 0 or 1

- Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

- Prior use of any anticancer therapy or experimental therapy for epithelial ovarian,
primary peritoneal or fallopian tube cancer

- Previous abdominal 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20101129

NCT ID:

NCT01493505

Start Date:

January 2012

Completion Date:

July 2020

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • Primary Peritoneal Cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Research SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteHonolulu, Hawaii  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteAmes, Iowa  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteHattiesburg, Mississippi  
Research SiteBillings, Montana  
Research SiteLas Vegas, Nevada  
Research SiteHooksett, New Hampshire  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteEnid, Oklahoma  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SitePawtucket, Rhode Island  
Research SiteCharleston, South Carolina  
Research SiteAberdeen, South Dakota  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteBennington, Vermont  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteAppleton, Wisconsin