Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

Mullerian Mixed Tumor of Ovary Clinical Trial

Official title:

Expanded Access Protocol to Provide Ficlatuzumab to P05538 Patient 0001-000412

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02090127
• Other study ID #: AV-299-13-103S
• Status: No longer available
• Phase: N/A
• First received: March 14, 2014
• Last updated: July 27, 2015

Study information

• Verified date: July 2015
• Source: AVEO Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Per original P05538 protocol

Exclusion Criteria:

• Per original P05538 protocol

Study Design

N/A

Related Conditions & MeSH terms

• Mixed Tumor, Mullerian
• Mullerian Mixed Tumor of Ovary
• Ovarian Neoplasms

Intervention

Drug:
• ficlatuzumab
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

Locations

Country	Name	City	State
United States	START	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AVEO Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

External Links

•   Continued Access of Ficlatuzumab to P05538 Patient