Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)

Study Overview
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Brief Summary
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This extension protocol is for those subjects that have completed the allowed duration of participation in an Endocyte-sponsored clinical trial of EC145 (vintafolide) and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study.

Detailed Description
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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.

Official Title
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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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: EC145


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have received prior treatment with EC145 within the context of an Endocyte-sponsored, IRB-approved clinical trial. Disease (i.e., cancer) that was considered stable at the last evaluation while participating in the previous EC145-containing study. Stable is defined as not having progression of disease per standard criteria (RECIST, etc). Stable disease may be indicated by previously attained complete or partial tumor shrinkage that has not progressed per standard criteria. No more than 10 weeks have elapsed since the last evaluation of stable disease. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Must have recovered (to baseline/stabilization) from prior EC145-associated acute toxicities. Adequate bone marrow reserve, hepatic, and renal function. Negative serum pregnancy test for women of childbearing potential Willingness to practice contraceptive methods for men and women of childbearing potential. Exclusion Criteria: Pregnancy. Development of a secondary malignancy requiring treatment. Symptomatic central nervous system (CNS) metastasis. History of receiving any investigational treatment or other systemic therapy directed at controlling cancer since the subject's last dose on the parent EC145 study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants<br>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. | Drug: EC145<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing adverse events |  | Up to 2 years | 
| Number of participants experiencing serious adverse events |  | Up to 2 years | 
| Number of participants discontinuing study drug due to adverse events |  | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Adenocarcinoma, Phase II, Lung, Non-small cell lung cancer, NSCLC, extension, EC145, Prior exposure to EC145