Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)
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.
Checked against the public recordLast updated Apr 8, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Endocyte
- Interventions being studied
- Drug: EC145
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Center for Blood and Cancer DisordersBethesda, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 8, 2021. Always confirm current availability with the study team.