A Phase 1 Continuous Intravenous Infusion Study of Terameprocol (EM-1421) in Subjects With Refractory Solid Tumors
Status:
Terminated
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
This is a Phase I continuous infusion study designed to explore if constant concentration
over time adds to the effectiveness of terameprocol without increasing toxicity. It will also
explore weekly dosing as an option.
Tumor response assessments will be performed following every two (2) cycles of therapy. All
subjects will undergo a follow-up visit 30 days following their last dose of terameprocol.
Circulating tumor cells (CTC) will be quantified pre dosing and on day 15 after first dose of
each cycle. Needle biopsy specimens will be taken prior to therapy and one week after first
dose, if possible, to assess for tumor markers (cdc-2 and survivin). Tumor markers, for
example prostate specific antigen (PSA) will also be measured on day 15 of each cycle (if
elevated on study entry). Pharmacokinetic parameters will be derived from analysis of blood
samples collected during the first 24 hour infusion.