Clinical Trials Directory

Trials / Terminated

TerminatedNCT01281254

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

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

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
223 (actual)
Sponsor
Amgen · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGAMG386 plus PLDAMG 386 is a first in class investigational anti angiogenic drug that provides potent and selective inhibition of angiopoietins. AMG 386 is designed to inhibit angiogenesis by sequestering Ang1 and Ang2, thereby preventing their interaction with the Tie2 receptor. Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
DRUGPlacebo plus PLDPegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)

Timeline

Start date
2011-04-18
Primary completion
2014-08-29
Completion
2017-04-19
First posted
2011-01-21
Last updated
2017-12-02

Locations

106 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Hungary, Italy, New Zealand, Poland, Singapore, Slovakia, Switzerland, Taiwan, United Kingdom

Source: ClinicalTrials.gov record NCT01281254. Inclusion in this directory is not an endorsement.