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An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
This study is currently recruiting participants.
Verified by Morphotek, February 2010
First Received: August 18, 2008   Last Updated: February 8, 2010   History of Changes
Sponsor: 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 platinum-resistant or refractory relapsed ovarian cancer


Condition Intervention Phase
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 Platinum-Resistant or Refractory Relapsed Ovarian Cancer

Resource links provided by NLM:


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, including primary peritoneal and fallopian tube malignancies, 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 platinum-containing chemotherapy. At least one of the lines of chemotherapy must have included a taxane.
  • Must have been treated with surgery NS and at least one line platinum-based chemotherapy;
  • Subjects may have received up to four additional lines of chemotherapy after they developed platinum-resistance.
  • 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 Weil, MD 610-423-6182 weil@morphotek.com

  Show 48 Study Locations
Sponsors and Collaborators
Morphotek
  More Information

No publications provided

Responsible Party: Morphotek, Inc ( Susan Weil, MD/ Study Director )
Study ID Numbers: MORAb003-003PR
Study First Received: August 18, 2008
Last Updated: February 8, 2010
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

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 February 08, 2010