Spots Global Cancer Trial Database for EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer
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Trial Identification
Brief Title: EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer
Official Title: 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
Study ID: NCT01485848
Conditions
Study Description
Brief Summary: Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in patients with ovarian cancer. Secondary Objectives: o Randomized Phase: Quantify any significant changes in the safety profile of weekly paclitaxel alone compared to the doublet combination of paclitaxel with EP-100. o Determine an initial benefit/risk profile for this new drug combination.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Investigational Site Number 840001, Greenbrae, California, United States
Investigational Site Number 840005, San Francisco, California, United States
Investigational Site Number 840007, Louisville, Kentucky, United States
Investigational Site Number 840010, Covington, Louisiana, United States
Investigational Site Number 840011, Shreveport, Louisiana, United States
Investigational Site Number 840503, Bozeman, Montana, United States
Investigational Site Number 840004, Middletown, Ohio, United States
Investigational Site Number 840008, Portland, Oregon, United States
Investigational Site Number 840006, Houston, Texas, United States
Investigational Site Number 840603, Kennewick, Washington, United States
Investigational Site Number 840103, Mount Vernon, Washington, United States
Investigational Site Number 840403, Seattle, Washington, United States
Investigational Site Number 840003, Seattle, Washington, United States
Investigational Site Number 840303, Tacoma, Washington, United States
Investigational Site Number 840203, Wenatchee, Washington, United States
Contact Details
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