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Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer Clinical research trials and Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer. Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer  Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer
Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer
For Condition: Ovarian Neoplasms
Status: Terminated
Sponsor(s): Seattle Genetics ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: 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)
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
AndrewSandler, Study Director, Seattle Genetics
Arizona Cancer Center
Tucson, Arizona, 85724
United States
California Hematology Oncology Medical Group
Torrance, California, 90505
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Mountain States Tumor Institute
Boise, Idaho, 83712
United States
Arlington Fairfax Hematology Oncology
Arlington, Virginia, 22205
United States
Sharp Healthcare
San Diego, California, 92123
United States
Additional Information:
Study ID Numbers: SG015-0003;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051584
Other Ovarian Neoplasms Studies:
1. Study of OSI-211 vs. Topotecan in Patients with Relapsed Epithelial Ovarian Cancer
2. Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma
3. Phase 1-2a Study of TLK286 in Combination with Paraplatin (Carboplatin) in Recurrent Ovarian Cancer
4. Phase 1-2a Study of TLK286 in Combination with Doxil in Platinum Refractory or Resistant Ovarian Cancer
5. Massage Therapy for Cancer-Related Fatigue
Related Studies:
Other Ovarian Neoplasms Clinical Trials
Other Arizona Clinical Trials
Other Tucson Clinical Trials
Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer
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