Clinical trial · Interventional
Study of Vintafolide (MK-8109, EC145) for the Treatment of Recurrent or Refractory Solid Tumors (MK-8109-006, EC-FV-01)
Protocol EC-FV-01: A Phase 1 Study of EC145 Administered in Weeks 1 and 3 of a 4-Week Cycle
NCT00308269CI-TRIAL-00016396completedPhase 1ClinicalTrials.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 is a Phase I clinical trial evaluating the safety and tolerability of escalating doses of vintafolide (EC145) in participants with relapsed or refractory advanced tumors. The primary objective of this study is to determine the safety and maximum tolerated dose of vintafolide given by intravenous bolus or infusion. The efficacy of the treatment will also be measured.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vintafolide IV Bolus | Drug | — | UNRESOLVED |
| Vintafolide IV Infusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Vintafolide 1.2 mg IV Bolus
- description
- Vintafolide 1.2 mg administered by IV bolus on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
- interventionNames
- Drug: Vintafolide IV Bolus
- type
- EXPERIMENTAL
- label
- Vintafolide 2.5 mg IV Bolus
- description
- Vintafolide 2.5 mg administered by IV bolus on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
- interventionNames
- Drug: Vintafolide IV Bolus
- type
- EXPERIMENTAL
- label
- Vintafolide 4.0 mg IV Bolus
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of neoplasm * No effective standard therapeutic options * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * \>=4 weeks post therapeutic radiation of chemotherapy \>=6 weeks for nitrosoureas and mitomycin C) and recovery from associated toxicities * Negative serum pregnancy test for women of child-bearing potential and willingness to practice contraceptive methods * Adequate bone marrow reserve, renal, and hepatic function Exclusion Criteria: * Concurrent hematological malignancies * Women who are pregnant or lactating * Evidence of symptomatic brain metastases * Receiving concomitant anticancer therapy (excluding supportive care) * Requires palliative radiotherapy at time of study entry
References
Publications (2)
- RESULTLi J, Sausville EA, Klein PJ, Morgenstern D, Leamon CP, Messmann RA, LoRusso P. Clinical pharmacokinetics and exposure-toxicity relationship of a folate-Vinca alkaloid conjugate EC145 in cancer patients. J Clin Pharmacol. 2009 Dec;49(12):1467-76. doi: 10.1177/0091270009339740. Epub 2009 Oct 16. PMID 19837906
- RESULTLorusso PM, Edelman MJ, Bever SL, Forman KM, Pilat M, Quinn MF, Li J, Heath EI, Malburg LM, Klein PJ, Leamon CP, Messmann RA, Sausville EA. Phase I study of folate conjugate EC145 (Vintafolide) in patients with refractory solid tumors. J Clin Oncol. 2012 Nov 10;30(32):4011-6. doi: 10.1200/JCO.2011.41.4946. Epub 2012 Oct 1. PMID 23032618