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

Phase 2

Completed

• Conditions: Solid Tumors
• Interventions: Drug: EC145

• Registration Number: NCT01002924
• Lead Sponsor: Endocyte

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

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 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.

Study Timeline

• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-28
• Study Start: 2009-12-31
• Primary Completion: 2013-12-11
• Study Completion: 2013-12-11
• Disposition First Submitted: 2021-03-30
• Disposition First Submitted QC: 2021-03-30
• Status Verified: 2021-04
• Disposition First Posted: 2021-04-01
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	EC145	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.

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing serious adverse events	Up to 2 years
Number of participants experiencing adverse events	Up to 2 years
Number of participants discontinuing study drug due to adverse events	Up to 2 years

Trial Locations

Locations (1)

Center for Blood and Cancer Disorders; 🇺🇸 Bethesda, Maryland, United States