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Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

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ClinicalTrials.gov Identifier: NCT02090127
Expanded Access Status : No longer available
First Posted : March 18, 2014
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.

Brief Summary:
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

Condition or disease Intervention/treatment
Mullerian Mixed Tumor of Ovary Drug: ficlatuzumab

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.

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Study Type : Expanded Access
Official Title: Expanded Access Protocol to Provide Ficlatuzumab to P05538 Patient 0001-000412



Intervention Details:
  • 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
    Other Names:
    • AV-299
    • SCH 900105

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Per original P05538 protocol

Exclusion Criteria:

  • Per original P05538 protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090127


Locations
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United States, Texas
START
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
AVEO Pharmaceuticals, Inc.

Additional Information:
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Responsible Party: AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02090127     History of Changes
Other Study ID Numbers: AV-299-13-103S
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Ovarian Neoplasms
Mixed Tumor, Mullerian
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type