months using the dose of CYT997 identified in the
Phase Ib component (Ph II).
Secondary endpoints Objective response rate, overall survival, safety
and tolerability, effects on pharmacodynamic
markers of vascular disruption and tumor apoptosis,
and pharmacokinetic analyses.
Blinding status Not blinded.
Product development Drug substance and drug product are manufactured to
status GMP standards.
Route 24 hour intravenous infusion dose (CYT997).
Frequency Day 2 of a 21 day cycle.
Dose-levels Maximum dose of 200 mg/m2 CYT997 dihydrochloride.
Number of trial
subjects Estimated 35 patients.
Subject selection Eligible patients must have glioblastoma multiforme
criteria that has progressed after surgery, radiation
therapy and temozolomide chemotherapy.
Trial location Initial site in Melbourne, Australia.
Expected completion 2Q 2010
Trial standard ICH-GCP
This trial follows the successful conclusion last year of the company's Phase I safety study for intravenous CYT997, in which a prolonged delay in tumor growth was observed in seven of the study's 31 advanced cancer patients.
Significant perturbations in tumor blood flow were also demonstrated, suggesting that CYT997 potently disrupts tumor blood vessels. Findings from this study were recently presented at the American Society of Clinical Oncology Annual Meeting which attracts some 30,000 cancer specialists from around the globe.
Cytopia is also investigating the safety and anti-vascular activity of
CYT997 when administered by mouth. Preliminary data from the company's
Phase I oral s
|SOURCE Cytopia Limited|
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