Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)
Completed · Phase 2
Conditions studied: Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT01002924
- Run by
- Endocyte
- People needed
- 1
- Starts
- 2009-12-31
- Expected to finish
- 2013-12-11
- Last updated by the study team
- 2021-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Center for Blood and Cancer Disorders — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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