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

Ovarian Neoplasms Clinical Trial

Official title:

A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00051584
• Other study ID #: SG015-0003
• Status: Terminated
• Phase: Phase 2
• First received: January 13, 2003
• Last updated: October 21, 2011
• Est. completion date: May 2003

Study information

• Verified date: October 2011
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00056017

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Brief Overview of 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

Drug:
• SGN-15 (cBR96-Doxorubicin Immunoconjugate)

• Gemzar (Gemcitabine)

Locations

Country	Name	City	State
United States	Arlington Fairfax Hematology Oncology	Arlington	Virginia
United States	Mountain States Tumor Institute	Boise	Idaho
United States	Sharp Healthcare	San Diego	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	California Hematology Oncology Medical Group	Torrance	California
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States,