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Sponsored by: |
Morphotek |
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 |
Ovarian Cancer |
Drug: MORAb-003 (farletuzumab) Drug: 0.9% Saline |
Phase II |
MedlinePlus related topics: | Cancer Ovarian Cancer |
ChemIDplus related topics: | Paclitaxel Sodium chloride |
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 |
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: Susan Weill, MD | 610-423-6182 | weill@morphotek.com |
Morphotek |
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 |
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