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

NCT01485848 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2014-06-10

No results posted yet for this study

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.

Conditions

  • Ovarian Cancer Recurrent

Interventions

DRUG

EP-100

Pharmaceutical form:Solution Route of administration: Intravenous

DRUG

Paclitaxel

Pharmaceutical form:Solution Route of administration: Intravenous

Sponsors & Collaborators

  • Esperance Pharmaceuticals Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01485848 on ClinicalTrials.gov