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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Clinical contraindications to use of paclitaxel, which include:
Contacts and Locations| Contact: Susan Weil, MD | 610-423-6182 | weil@morphotek.com |
Show 48 Study Locations
More Information
| 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 |
|
ovarian cancer relapsed ovarian cancer refractory ovarian cancer |
|
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 |