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A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers


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 Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers


Inclusion Criteria:



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

- Gynecologic Oncology Group (GOG) Performance Status of 0 or 1

- Life expectancy >= 3 months (per investigator opinion)

- Histologically or cytologically documented invasive epithelial ovarian cancer,
primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma ,
mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with
borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with
clear cell or mucinous histology are excluded)

- Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer,
or fallopian tube cancer including at least a unilateral oophorectomy

- Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 with modifications

- Subjects must have had one prior platinum-based chemotherapeutic regimen for
management of primary disease containing carboplatin, cisplatin, or another
organoplatinum compound. This initial treatment may have included intraperitoneal
therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy
administered after surgical or non-surgical assessment.

- Adequate organ and hematological function

- Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and
diastolic blood pressure <= 90 mmHg prior to randomization. The use of
anti-hypertensive medications to control hypertension is permitted

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

Exclusion Criteria:

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

- Subjects who have received paclitaxel as consolidation therapy, maintenance, or
monotherapy are excluded

- Subjects with primary platinum-refractory disease

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

- Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from
all radiotherapy-related toxicities

- Previous abdominal or pelvic radiotherapy

- History of arterial or venous thromboembolism within 12 months prior to randomization

- History of clinically significant bleeding within 6 months prior to randomization

- History of central nervous system metastasis

- Has not yet completed a 21 day washout period prior to randomization for any previous
anti cancer systemic therapies (30 days for prior bevacizumab)

- Enrolled in or has not yet completed at least 30 days (prior to randomization) since
ending other investigational device or drug, or currently receiving other
investigational treatments

- Unresolved toxicities from prior systemic therapy that are Common Terminology
Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except
alopecia

- Known active or ongoing infection (except uncomplicated urinary tract infection
[UTI]) within 14 days prior to randomization

- Currently or previously treated with AMG 386, or other molecules that inhibit the
angiopoietins or Tie2 receptor

- Treatment within 30 days prior to randomization with strong immune modulators
including but not limited to systemic cyclosporine, tacrolimus, sirolimus,
mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and
lenalidomide

- Clinically significant cardiovascular disease within 12 months prior to randomization

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

- Minor surgical procedures, except placement of tunneled central venous access device
within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor
surgical procedure.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-Free Survival

Outcome Time Frame:

8 Months on average

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Japan: Pharmaceuticals and Medical Devices Evaluation Center

Study ID:

20090508

NCT ID:

NCT01204749

Start Date:

October 2010

Completion Date:

April 2017

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • AMGEN
  • AMG 386
  • Angiogenesis Inhibitors
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Paclitaxel
  • Ovarian Cancer
  • TRINOVA-1
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteHonolulu, Hawaii  
Research SiteBoise, Idaho  
Research SiteArlington Heights, Illinois  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteHooksett, New Hampshire  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAuburn, Washington  
Research SiteAppleton, Wisconsin