An Efficacy and Safety Study of MORAb-003 in First Platinum-Resistant or Refractory Relapsed Ovarian Cancer - NCT00738699-Hamilton - 005 (Clinical Trial 237974)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy237974.aspx
|
** Please review additional "Nearby Studies" on right ----->
This is an archived study that is no longer available, if you
would like to find active studies please search our studies.
|
|
 |
 |
|
| City: |
|
Hamilton |
|
Country:
|
|
Canada |
|
|
|
| Conditions: |
|
Ovarian Cancer |
| 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
|
| Study summary: |
|
|
| 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). |
|
|
|
|
|
|
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
September 1, 2009 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|