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

NCT ID: NCT01002924

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-12-11

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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All Participants

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.

Group Type: EXPERIMENTAL

EC145

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endocyte

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siu-Long Yao

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Center for Blood and Cancer Disorders

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

EC-FV-05

Identifier Type: -

Identifier Source: secondary_id

8109-010

Identifier Type: -

Identifier Source: org_study_id