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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002924
• Other study ID #: 8109-010
• Secondary ID: EC-FV-05
• Status: Completed
• Phase: Phase 2
• Start date: December 31, 2009
• Est. completion date: December 11, 2013

Study information

• Verified date: April 2021
• Source: Endocyte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 11, 2013
• Est. primary completion date: December 11, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Center for Blood and Cancer Disorders	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Endocyte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing adverse events		Up to 2 years
Primary	Number of participants experiencing serious adverse events		Up to 2 years
Primary	Number of participants discontinuing study drug due to adverse events		Up to 2 years