Full Text View
Tabular View
No Study Results Posted
Related Studies
An Efficacy and Safety Study of MORAb-003 in First Platinum-Resistant or Refractory Relapsed Ovarian Cancer
This study is currently recruiting participants.
Verified by Morphotek, December 2008
First Received: August 18, 2008   Last Updated: May 4, 2009   History of Changes
Sponsored by: Morphotek
Information provided by: Morphotek
ClinicalTrials.gov Identifier: NCT00738699
  Purpose

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
Ovarian Cancer
Drug: MORAb-003 (farletuzumab)
Drug: 0.9% Saline
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
U.S. FDA Resources
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

Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Progression-free survival using GCIG response criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall response,overall survival and cardiac substudy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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
1: Active Comparator
Paclitaxel with MORAb-003(farletuzumab)
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
2: Placebo Comparator
Paclitaxel with Placebo
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of non-mucinous epithelial ovarian cancer measurable by CT or MRI scan, or progression defined by radiologic criteria or by biomarker (CA-125 ≥ 1.5 x ULN) assessed within 4 weeks prior to study entry
  • Must have relapsed within 6 months of first or second line platinum-containing chemotherapy. At least one of the lines of chemotherapy must have included a taxane.
  • Must have been initially treated with surgery NS first or second line platinum-based chemotherapy;
  • Subjects must be candidate for repeat paclitaxel treatment

Exclusion Criteria:

  • Clinical contraindications to use of paclitaxel, which include:

    1. persistent Grade 2 or greater peripheral neuropathy
    2. prior hypersensitivity reaction that persisted despite rechallenge with or without desensitization or resulted in bronchospasm or hemodynamic instability or was at least Grade 2 and resulted in medication discontinuation
  • Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas). Note: EOC with prior diagnosis of a low malignant potential tumor that has been surgically resected is acceptable provided the subject did
  • Prior radiation therapy is excluded with the exception that it is allowable only if measurable disease for ovarian cancer is completely outside the radiation portal
  • Known allergic reaction to a prior monoclonal antibody therapy or have any documented human anti-human antibody (HAHA).
  • Previous treatment with MORAb-003 (farletuzumab).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738699

Contacts
Contact: Debasis Chakrabarti, MD, PhD 610-423-6176 dchakrabarti@morphotek.com

Locations
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            
Sponsors and Collaborators
Morphotek
  More Information

No publications provided

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

Keywords provided by Morphotek:
ovarian cancer
relapsed ovarian cancer
refractory ovarian cancer

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian Neoplasms
Paclitaxel
Gonadal Disorders
Genital Neoplasms, Female
Ovarian Cancer
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 06, 2009