Ovarian Cancer Clinical Trial
Official title:
Protocol EC-FV-02: A Phase II Study of EC145 in Patients With Advanced Ovarian and Endometrial Cancers
This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in participants with advanced ovarian and endometrial cancers.
This is a Phase II clinical trial of vintafolide administered to participants with advanced
ovarian and endometrial cancers.
Vintafolide is a drug that is specifically designed to enter cancer cells via the folate
vitamin receptor (FR). Experimental evidence shows that this target receptor is expressed on
virtually all ovarian cancers as well as the majority of endometrial cancers. Early clinical
evidence in a small number of Phase I patients suggests that vintafolide may have antitumor
effect in women with advanced ovarian cancer and that it is generally well-tolerated. This
evidence suggests that vintafolide may be useful as chemotherapy against advanced ovarian
and endometrial cancers. The primary objective of Part A of this study is to collect data on
clinical benefit produced by therapy with vintafolide. The primary objective of Part B of
this study is to collect data on the safety and efficacy of vintafolide.
All participants will undergo imaging with the FR targeting investigational imaging agent
ertafolide (EC20, FolateScan) during the screening period to confirm eligibility for the
treatment portion of the clinical trial. Clinical evidence suggests that ertafolide may be
used to identify women with cancers that express the target receptor.
Information about the safety and tolerability of both vintafolide and ertafolide will be
assessed.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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