drugset / Trial / NCT00051584

Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer

NCT00051584 ↗

Phase 2 Terminated 60 enrolled Seagen Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, randomized phase II trial comparing treatment with a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly Gemzar® (Gemcitabine) to treatment with Gemzar® alone. The primary objectives of this study are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar®, to estimate the clinical response rate and to estimate the duration of response of this combination therapy administered to patients with advanced ovarian cancer, compared to treatment with Gemzar® alone.

Timeline

Start
—
Primary completion
—
Completion
2003-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule — —
Subject SGN-15 Monoclonal antibody — —

Indications