Clinical trial · Interventional
Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)
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
NCT01002924CI-TRIAL-00051104completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EC145 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All Participants
- description
- 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.
- interventionNames
- Drug: EC145
Primary outcomes (3)
- measure
- Number of participants experiencing adverse events
- timeFrame
- Up to 2 years
- measure
- Number of participants experiencing serious adverse events
- timeFrame
- Up to 2 years
- measure
- Number of participants discontinuing study drug due to adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.