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

Stopped early · Phase 2

Conditions studied: Ovarian Neoplasms

In brief

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.

Key facts

Study ID

NCT00051584

Run by

Seagen Inc.

People needed

60

Expected to finish

2003-05-01

Last updated by the study team

2011-10-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• Sharp Healthcare — San Diego, California, United States
• California Hematology Oncology Medical Group — Torrance, California, United States
• Mountain States Tumor Institute — Boise, Idaho, United States
• Arlington Fairfax Hematology Oncology — Arlington, Virginia, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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