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

Phase 2

Terminated

• Conditions: Ovarian Neoplasms

• Registration Number: NCT00051584
• Lead Sponsor: Seagen Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-01-13
• Study First Submitted QC: 2003-01-14
• Study First Posted: 2003-01-15
• Study Completion: 2003-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-21
• Last Update Posted: 2011-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Patients must have pathologically confirmed ovarian cancer, which is advanced or recurrent carcinoma, who have failed at least two, but no more than three prior therapies for metastatic disease

• Patients must have > 20% Lewis-y antigen expression documented by immunohistochemistry

• LVEF > 50% by echo or MUGA

• Must be platinum resistant as defined by:

  • Progression while on initial platinum therapy or
  • Progression while on retreatment with initial platinum regimen or
  • Relapse < 6 months after initial therapy

Brief Overview of

Exclusion Criteria

• Patients who have had prior therapy with Gemzar®
• Cumulative anthracycline exposure > 300 mg/m2
• More than three prior chemotherapy regimens for ovarian cancer (Retreatment with Taxane/Platinum after initial combination is considered only one regimen)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (6)

California Hematology Oncology Medical Group; 🇺🇸 Torrance, California, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Mountain States Tumor Institute; 🇺🇸 Boise, Idaho, United States

Arlington Fairfax Hematology Oncology; 🇺🇸 Arlington, Virginia, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Sharp Healthcare; 🇺🇸 San Diego, California, United States