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Terminated/Withdrawn
Sponsor ID
20060517

AMG 386 (trebananib) in Ovarian Cancer (TRINOVA-2)

Sponsor ID
20060517
Clinicaltrials.gov ID
NCT01281254
EUCTIS ID
N/A
EudraCT ID
2009-017946-30
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Study Details

To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.

Additional Study Details

Phase
Phase 3
Product
AMG 386
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
223
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 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.

Secondary Outcome Measures

• To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival

Timeframe: weekly

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Annandale, VA, United States, 22003
Status
Completed
Location
Research Site
Asheville, NC, United States, 28806
Status
Completed
Location
Research Site
Bismarck, ND, United States, 58501
Status
Completed
Location
Research Site
Orlando, FL, United States, 32806
Status
Completed
Location
Research Site
St. Louis Park, MN, United States, 55426
Status
Completed
Location
Research Site
Stamford, CT, United States, 06902
Status
Completed
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Study Info
Age
18+ years
Condition
  • Fallopian Tube Cancer
    • Show more
  • Ovarian Cancer
  • Peritoneal Cancer
    • Sex
    Assigned Female at Birth
    Trial Dates
    Apr 2011 - Aug 2014
    Inclusion and Exclusion Criteria
    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