EP-100, a Novel LHRH Receptor-Targeted, Membrane-Disrupting Peptide, Plus Paclitaxel Versus Paclitaxel Alone for Refractory or Recurrent Ovarian Cancer: A Phase II, Randomized, Multicenter Trial
Total duration of the study for each participant is 9 to 10 months, consisting of a 1 month
screening period, a 6 to 7 months treatment period, and a 30 day follow-up. All patients
with stable disease or who have achieved partial or complete response and for whom dosing
has been safe and reasonably well-tolerated may continue additional treatment cycles on the
same regimen. Any patient whose imaging assessment shows disease progression after receiving
at least two cycles of single agent weekly paclitaxel on ARM 1 may then be offered treatment
with the combination of EP-100 plus paclitaxel in the same dose regimen as ARM 2.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with dose limiting toxicities (DLTs) at different doses
Up to 30 weeks
Yes
United States: Food and Drug Administration
ACT12601
NCT01485848
February 2012
October 2013
Name | Location |
---|---|
Investigational Site Number 840001 | Vallejo, California 94589 |
Investigational Site Number 840005 | San Francisco, California 94117 |
Investigational Site Number 840004 | Cincinnati, Ohio 45267-0542 |
Investigational Site Number 840006 | San Antonio, Texas 78229 |
Investigational Site Number 840007 | Paducah, Kentucky 42002 |
Investigational Site Number 840103 | Mount Vernon, Washington 98273 |
Investigational Site Number 840403 | Seattle, Washington 98112 |
Investigational Site Number 840003 | Seattle, Washington 98115 |
Investigational Site Number 840010 | Covington, Louisiana 70433 |
Investigational Site Number 840011 | Shreveport, Louisiana 71103 |
Investigational Site Number 840503 | Bozeman, Montana 58715 |
Investigational Site Number 840008 | Portland, Oregon 97227-1191 |
Investigational Site Number 840603 | Kennewick, Washington 99336 |
Investigational Site Number 840303 | Tacoma, Washington 98415-0299 |
Investigational Site Number 840203 | Wenatchee, Washington 98801 |