EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer Recurrent
• Interventions: Drug: EP-100; Drug: Paclitaxel

• 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.

Study Timeline

• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-06
• Study Start: 2012-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-09
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

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

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