Trial intelligence / Profile preview

FOCUS: Fragmin in Ovarian Cancer

NCT00239980Phase 2

Key facts

Status: Completed
Start: Oct 2005
Primary completion: Jan 2010
Countries: 1
Sponsor: Ontario Clinical Oncology Group
Modality: Recombinant Proteins and Enzymes

Drugs: dalteparin
Conditions: epithelial ovarian carcinoma (EOC)

Overview

Phase 2, randomised, open-label trial of dalteparin in epithelial ovarian carcinoma (EOC) (3 arms), sponsored by Ontario Clinical Oncology Group. Primary endpoint: Disease Response. Started Oct 2005; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

50 IU/kg
Dalteparin 50 IU/kg daily + Standard Chemo
100 IU/kg
Dalteparin 100 IU/kg daily + Standard Chemo
150 IU/kg
Dalteparin 150 IU/kg daily + Standard Chemo

Who it enrols

Women aged 18-75 with newly diagnosed, histologically proven epithelial ovarian carcinoma (FIGO stage IIB-IV) and adequate organ function. Excludes prior EOC therapy, other malignancies within 5 years, and significant cardiac or bleeding risks.

Endpoints

Primary

Disease Responseup to day 1 of cycle 6

Secondary

Symptomatic Venous Thromboembolismup to 7 days after last dose of dalteparin
Bleedingup to 24 hours after last dose of dalteparin
Complianceup to the end of cycle 3
Deathup to the last day of follow-up

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