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Sponsored by: |
Morphotek |
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Information provided by: | Morphotek |
ClinicalTrials.gov Identifier: | NCT00738699 |
This research is being done to find out if paclitaxel works better when given together with an experimental drug called MORAb-003(farletuzumab) or alone in patients with first platinum-resistant or refractory relapsed ovarian cancer
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: MORAb-003 (farletuzumab) Drug: 0.9% Saline |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab)in Combination With Paclitaxel Therapy in Subjects With First Platinum-Resistant or Refractory Relapsed Ovarian Cancer |
Estimated Enrollment: | 126 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Paclitaxel with MORAb-003(farletuzumab)
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Drug: MORAb-003 (farletuzumab)
2.5mg/kg IV day 1 weeks 1-12 (cycle 1); day 1 weeks 1-3 with week 4 as rest week for subsequent cycles
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2: Placebo Comparator
Paclitaxel with Placebo
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Drug: 0.9% Saline
2.5mg/kg IV day 1 weeks 1-12 (cycle 1); day 1 weeks 1-3 with week 4 as rest week for subsequent cycles
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Clinical contraindications to use of paclitaxel, which include:
Contact: Debasis Chakrabarti, MD, PhD | 610-423-6176 | dchakrabarti@morphotek.com |
United States, California | |
California Cancer Care, Inc. | Recruiting |
Greenbrae, California, United States, 94904 | |
Contact: Jaime Chang 415-925-5040 jchang@cal-cancer-care.com | |
Principal Investigator: Peter Eisenberg, MD | |
United States, Illinois | |
Hematology Oncology Associates of Illinois | Recruiting |
Skokie, Illinois, United States, 60076 | |
Contact: Megan Dunn 847-568-9930 dunnm@pk-research.com | |
Contact: Clay Packard 773-414-9716 packc@pk-research.com | |
Principal Investigator: Ira Oliff, MD | |
United States, Indiana | |
St. Vincent Gynecologic Oncology | Recruiting |
Indianapolis, Indiana, United States, 46260 | |
Contact: Shirley Morrison 317-415-6747 samorri1@stvincent.org | |
Principal Investigator: Gregory Sutton, MD | |
United States, Maryland | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Jessica Wakefield 410-955-8849 jrober31@jhmi.edu | |
Principal Investigator: Deborah Armstrong, MD | |
United States, New Jersey | |
Cooper Health System | Recruiting |
Vorhees, New Jersey, United States, 08043 | |
Contact: Maria DeFrancesco 856-325-6733 defrances-maria@cooperhealth.edu | |
Principal Investigator: David Warshal, MD | |
United States, New York | |
Schwartz Gynecologic Oncology, PLLC | Recruiting |
Brightwaters, New York, United States, 11718 | |
Contact: Jaclyn Frizalone 631-894-1033 jf@schwartzoncology.com | |
Principal Investigator: Benjamin Schwartz, MD | |
United States, Pennsylvania | |
Magee-Women's Hospital of UPMC | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Carol Onufer 412-641-3133 onuferc@magee.edu | |
Principal Investigator: Robert Edwards, MD | |
United States, Texas | |
South Texas Oncology & Hematology PA | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Holly Beever, RN 210-593-2572 holly.beever@stoh.com | |
Principal Investigator: Allan White, MD | |
United States, Virginia | |
Northern Virginia Pelvic Surgery Associates | Recruiting |
Annandale, Virginia, United States, 22003 | |
Contact: Sheila Whitt 703-698-7100 ext 318 swhitt@nvpsa.net | |
Principal Investigator: Annette Bicher, MD | |
United States, Washington | |
Northwest Medical Specialties | Active, not recruiting |
Tacoma, Washington, United States, 98405 | |
Australia, Queensland | |
Royal Brisbane & Women's Hospital | Recruiting |
Herston, Queensland, Australia, 4029 | |
Contact: Wendy Pritchard +61 7 3636 4109 wendy_pritchard@health.qld.gov.au | |
Principal Investigator: Jeffrey Goh, MD | |
Australia, Victoria | |
The Royal Women's Hospital | Recruiting |
Parkville, Victoria, Australia, 3052 | |
Contact: Margot Osinski +61 3 8345 3547 margot.osinski@thewomens.org.au | |
Principal Investigator: Richard De Boer, MD | |
Mercy Hospital for Women | Recruiting |
Heidelberg, Victoria, Australia, 3084 | |
Contact: Christine Smith +61 3 8458 4876 csmith@mercy.com.au | |
Principal Investigator: Serene Foo, MD | |
Canada, Ontario | |
Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V 5C2 | |
Contact: Loretta Anderson 905-387-9495 ext 64418 loretta.anderson@jcc.hhsc.ca | |
Principal Investigator: Laurie Elit, MD |
Responsible Party: | Morphotek, Inc ( Debasis Chakrabarti, M.D., PhD/ Study Director ) |
Study ID Numbers: | MORAb003-003PR |
Study First Received: | August 18, 2008 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00738699 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ovarian cancer relapsed ovarian cancer refractory ovarian cancer |
Genital Diseases, Female Ovarian Neoplasms Paclitaxel Gonadal Disorders Genital Neoplasms, Female Ovarian Cancer |
Endocrine System Diseases Urogenital Neoplasms Endocrinopathy Ovarian Diseases Endocrine Gland Neoplasms |
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |