MedTrace Logo

Efficacy and Safety Study of Sorafenib With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer

NCT01047891 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2015-02-18

No results posted yet for this study

Summary

It is assumed, that the patients of the standard arm show a median progression-free survival time of 4.4 months those of the experimental arm of at least 6.9 months. Assuming a recruitment period of 18 months and follow-up for at least 12 months a total sample size of 174 patients is required (two-sided, α=0.05, 80% power). To account for 5% drop-outs 184 patients will be randomized.

A Data Monitoring and Safety Board (DMSB) will be established. This board will evaluate the safety profile of the drug combination after 6 patients and after 12 patients have received 1 cycle of treatment.

Conditions

Interventions

DRUG

Sorafenib

Topotecan 1,25 mg/m²/d administered as an i.v. infusion over 30 minutes once daily on days 1-5, every 21 days and Sorafenib 400 mg orally twice daily (total daily dose 800 mg) administered

Sponsors & Collaborators

  • JSehouli

    lead OTHER

Principal Investigators

  • Jalid Sehouli Sehouli, Professor · Charité Campus Virchow-Klinikum, Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01047891 on ClinicalTrials.gov