Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)
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|ClinicalTrials.gov Identifier: NCT01002924|
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: EC145||Phase 2|
This extension protocol is for those subjects that have completed the allowed duration of participation in an Endocyte-sponsored clinical trial of EC145 and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study.
Following confirmation of eligibility, subjects will receive intravenously-administered EC145 at a dose of 2.5 mg. Dosing will occur on Monday, Wednesday, and Friday of weeks 1 and 3 of each 4-week cycle. No therapy will be administered during weeks 2 and 4. Subjects randomized to non-EC145-containing treatment arms of EC145 trials are not eligible for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Protocol EC-FV-05: An Open-label, Multi-center, Extension Study of EC145 Administered Weeks 1 and 3 of a 4-Week Cycle in Subjects Enrolled in a Previous Study With EC145|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||December 11, 2013|
|Actual Study Completion Date :||December 11, 2013|
Experimental: All Participants
All participants invited to enroll on study will receive EC145 (vintafolide) 2.5 mg by intravenous bolus on Monday, Wednesday, and Friday of Weeks 1 and 3 in each 4-week cycle.
EC145 will be administered intravenously at a dose of 2.5 mg. Dosing will occur on Monday, Wednesday, and Friday of weeks 1 and 3 of each 4-week cycle. No therapy will be administered during weeks 2 and 4.
- Number of participants experiencing adverse events [ Time Frame: Up to 2 years ]
- Number of participants experiencing serious adverse events [ Time Frame: Up to 2 years ]
- Number of participants discontinuing study drug due to adverse events [ Time Frame: Up to 2 years ]
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): NCT01002924
|United States, Maryland|
|Center for Blood and Cancer Disorders|
|Bethesda, Maryland, United States, 20817|
|Study Director:||Siu-Long Yao||Merck Sharp & Dohme Corp.|