Lung Cancer Trials Ask AI to find trials
CompletedPhase 2NCT01002924
Official study title

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

Study 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.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEC145

The study team can explain what participation involves.

Who it may be forSolid Tumors

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 8, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Endocyte

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Endocyte
Interventions being studied
Drug: EC145
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Center for Blood and Cancer DisordersBethesda, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 8, 2021. Always confirm current availability with the study team.

View original record ↗