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A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer


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

Thank you

Trial Information

A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer


Inclusion Criteria:



- Histologically or cytologically documented invasive epithelial ovarian, primary
peritoneal, or fallopian tube cancer

- Radiographically documented disease progression either on or following the last dose
of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube
cancer

- Subjects must have had one prior platinum-based chemotherapeutic regimen for
management of primary disease containing carboplatin, cisplatin, or another
organoplatinum compound.

- Female 18 years of age or older at the time the written informed consent is obtained

- Adequate organ and hematological function

Exclusion Criteria:

- Subjects who have received more than 3 previous regimens of anti cancer therapy for
epithelial ovarian, primary peritoneal or fallopian tube cancer

- Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any
anthracycline-based or mitoxantrone-based chemotherapy

- Subjects with primary platinum-refractory disease

- Subjects with platinum-free interval (PFI) > 12 months from their last platinum based
therapy

- History of central nervous system metastasis

- Major surgery within 28 days prior to randomization or still recovering from prior
surgery

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications

Outcome Time Frame:

Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Belgium: Grand Hôpital de Charleroi comité d'éthique

Study ID:

20060517

NCT ID:

NCT01281254

Start Date:

March 2011

Completion Date:

June 2018

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian tube cancer
  • Primary peritoneal cancer
  • AMG386
  • Pegylated Liposomal Doxorubicin
  • Recurrent epithelial ovarian cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Research Site Anaheim, California  
Research Site Danbury, Connecticut  
Research Site Boca Raton, Florida  
Research Site Arlington Heights, Illinois  
Research Site Alexandria, Minnesota  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Bismarck, North Dakota  
Research Site Allentown, Pennsylvania  
Research Site Aberdeen, South Dakota  
Research Site Abilene, Texas  
Research Site Abington, Virginia  
Research Site Appleton, Wisconsin