Study of Vintafolide (MK-8109, EC145) for the Treatment of Recurrent or Refractory Solid Tumors (MK-8109-006, EC-FV-01)

Completed · Phase 1

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT00308269

Run by

Endocyte

People needed

32

Starts

2006-03-01

Expected to finish

2008-07-01

Last updated by the study team

2014-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Greenebaum Cancer Center at University of Maryland Medical Center — Baltimore, Maryland, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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