Status:
COMPLETED
Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)
Lead Sponsor:
Endocyte
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
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 benefi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01002924
Start Date
December 31 2009
End Date
December 11 2013
Last Update
April 8 2021
Active Locations (1)
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1
Center for Blood and Cancer Disorders
Bethesda, Maryland, United States, 20817