Overview

This trial is active, not recruiting.

Condition solid tumors
Treatment ec145
Phase phase 2
Sponsor Endocyte
Start date December 2009
End date October 2017
Trial size 1 participant
Trial identifier NCT01002924, 8109-010, EC-FV-05

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 clinical benefit (stable disease or better) at the time that they completed participation in that study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
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.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Endocyte.