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An Efficacy and Safety Study of MORAb-003 in First Platinum-Resistant or Refractory Relapsed Ovarian Cancer

This study is not yet open for participant recruitment.
Verified by Morphotek, August 2008

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   

ChemIDplus related topics:   Paclitaxel    Sodium chloride   

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: Susan Weill, MD     610-423-6182     weill@morphotek.com    

Sponsors and Collaborators
Morphotek
  More Information


Responsible Party:   Morphotek, Inc ( Susan Weil, M.D./ Study Director )
Study ID Numbers:   MORAb003-003PR
First Received:   August 18, 2008
Last Updated:   August 18, 2008
ClinicalTrials.gov Identifier:   NCT00738699
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 cancer
Ovarian Neoplasms
Paclitaxel
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on October 15, 2008




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