Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer
A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer
1 other identifier
interventional
60
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2003
CompletedFirst Posted
Study publicly available on registry
January 15, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedOctober 24, 2011
October 1, 2011
January 13, 2003
October 21, 2011
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (6)
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Sharp Healthcare
San Diego, California, 92123, United States
California Hematology Oncology Medical Group
Torrance, California, 90505, United States
Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Arlington Fairfax Hematology Oncology
Arlington, Virginia, 22205, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andrew Sandler, MD
Seagen Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 13, 2003
First Posted
January 15, 2003
Study Completion
May 1, 2003
Last Updated
October 24, 2011
Record last verified: 2011-10