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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 Site Alabaster, Alabama  
Research Site Mesa, Arizona  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Honolulu, Hawaii  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Ames, Iowa  
Research Site Baltimore, Maryland  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Hattiesburg, Mississippi  
Research Site Billings, Montana  
Research Site Las Vegas, Nevada  
Research Site Hooksett, New Hampshire  
Research Site Belleville, New Jersey  
Research Site Albuquerque, New Mexico  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Enid, Oklahoma  
Research Site Bend, Oregon  
Research Site Allentown, Pennsylvania  
Research Site Pawtucket, Rhode Island  
Research Site Charleston, South Carolina  
Research Site Aberdeen, South Dakota  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Ivins, Utah  
Research Site Bennington, Vermont  
Research Site Abington, Virginia  
Research Site Auburn, Washington  
Research Site Appleton, Wisconsin