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

NCT00051584 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-10-24

No results posted yet for this study

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.

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

SGN-15 (cBR96-Doxorubicin Immunoconjugate)

DRUG

Gemzar (Gemcitabine)

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Sandler, MD · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Completion
2003-05-31

Countries

  • United States

Study Locations

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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 NCT00051584 on ClinicalTrials.gov