Status:
COMPLETED
Study of Vintafolide (MK-8109, EC145) for the Treatment of Recurrent or Refractory Solid Tumors (MK-8109-006, EC-FV-01)
Lead Sponsor:
Endocyte
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
This is a dose escalation study of vintafolide administered by intravenous (IV) bolus or infusion during weeks 1 and 3 of a 4-week cycle to participants with solid tumors refractory to current therapi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00308269
Start Date
March 1 2006
End Date
July 1 2008
Last Update
December 19 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
2
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201