EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer
- Registration Number
- NCT01485848
- Lead Sponsor
- Esperance Pharmaceuticals Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel EP-100 A single 1 hour intravenous infusion every week for 6 cycles (each cycle is 4 weeks) Paclitaxel + EP-100 Paclitaxel Paclitaxel every week plus EP-100 twice weekly by 1 hour intravenous infusion for the first 3 weeks of each 4 week cycle for 6 cycles (each cycle is 4 weeks)
- Primary Outcome Measures
Name Time Method Number of patients with dose limiting toxicities (DLTs) at different doses Up to 30 weeks Overall Response Rate (ORR) Up to 30 weeks
- Secondary Outcome Measures
Name Time Method Duration of Response - Time Up to 18 months Number of Participants with Adverse Events Up to 18 months Overall Survival (OS) - Time Up to 18 months Time to Progression (TTP) - Time Up to 18 months Progression-free Survival - Time Up to 18 months
Related Research Topics
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Trial Locations
- Locations (15)
Investigational Site Number 840004
🇺🇸Middletown, Ohio, United States
Investigational Site Number 840003
🇺🇸Seattle, Washington, United States
Investigational Site Number 840503
🇺🇸Bozeman, Montana, United States
Investigational Site Number 840011
🇺🇸Shreveport, Louisiana, United States
Investigational Site Number 840203
🇺🇸Wenatchee, Washington, United States
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 840008
🇺🇸Portland, Oregon, United States
Investigational Site Number 840006
🇺🇸Houston, Texas, United States
Investigational Site Number 840403
🇺🇸Seattle, Washington, United States
Investigational Site Number 840603
🇺🇸Kennewick, Washington, United States
Investigational Site Number 840103
🇺🇸Mount Vernon, Washington, United States
Investigational Site Number 840303
🇺🇸Tacoma, Washington, United States