Back to resultsProtocol to Allow Continued Access of Ficlatuzumab to P05538 Patient
Primary Purpose
Mullerian Mixed Tumor of Ovary
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
ficlatuzumab
Sponsored by
About this trial
This is an expanded access trial for Mullerian Mixed Tumor of Ovary
Eligibility Criteria
Inclusion Criteria:
- Per original P05538 protocol
Exclusion Criteria:
- Per original P05538 protocol
Sites / Locations
- START
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02090127
First Posted
March 14, 2014
Last Updated
July 27, 2015
Sponsor
AVEO Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02090127
Brief Title
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient
Official Title
Expanded Access Protocol to Provide Ficlatuzumab to P05538 Patient 0001-000412
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AVEO Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient
Detailed Description
This treatment protocol will serve as a mechanism to continue to provide ficlatuzumab to patient 0001-000412, who was previously enrolled under protocol P05538 and whom the investigator believes is deriving clinical benefit from ficlatuzumab treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mullerian Mixed Tumor of Ovary
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ficlatuzumab
Other Intervention Name(s)
AV-299, SCH 900105
Intervention Description
humanized anti-hepatocyte growth factor (HGF) monoclonal antibody IV administration at 16.5mg/kg every 2 weeks with a ±2 day window around dosing dates, as long as subject is deriving clinical benefit as determined by the Investigator
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Per original P05538 protocol
Exclusion Criteria:
Per original P05538 protocol
Facility Information:
Facility Name
START
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.gov/show/NCT00725634
Description
Continued Access of Ficlatuzumab to P05538 Patient
Learn more about this trial
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient
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