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Annals of Oncology 13:1259-1263, 2002
© 2002 European Society for Medical Oncology


Original Paper

Neovastat (Æ-941) in refractory renal cell carcinoma patients: report of a phase II trial with two dose levels

G. Batist1,+, F. Patenaude1, P. Champagne2, D. Croteau2, C. Levinton3, C. Hariton2, B. Escudier4 and E. Dupont2

1 McGill Center for Translational Research in Cancer, McGill University, Montréal; 2 Les Laboratoires Æterna, Québec; 3 3210308 Canada Inc., Montréal, Canada; 4 Institut Gustave Roussy, Villejuif, France

Received 3 October 2001; revised 19 December 2001; accepted 9 January 2002

Background:

renal cell carcinoma (RCC) is a potential target for anti-angiogenic drugs because of its high vascularization. Neovastat (Æ-941) is an inhibitor of angiogenesis with a mechanism of action that could prove beneficial in the treatment of RCC.

Patients and design

A phase II trial was conducted to identify the long-term safety profile of Neovastat in advanced cancer patients and to obtain preliminary information on its efficacy in solid tumors refractory to standard treatments. Neovastat (60 or 240 ml/day) was administered orally (b.i.d.) to 144 patients with solid tumors refractory to standard therapies or for whom no standard treatments were available.

Results:

A survival analysis was conducted on 22 patients with a primary diagnosis of refractory RCC to determine whether the dose of Neovastat had any effect. A significant relationship between dose and survival was observed; the median survival time was significantly longer (16.3 versus 7.1 months; P = 0.01) in patients treated with Neovastat 240 ml/day (n = 14) compared with patients receiving 60 ml/day (n = 8). No dose-limiting toxicity was reported. The most frequent adverse event was taste alteration (13.6%).

Conclusions:

Neovastat is well tolerated by advanced cancer patients at doses of 60 and 240 ml/day. The higher dose of Neovastat administered in this trial is associated with a survival benefit in RCC, which is not explained by differences in major prognostic factors.

Key words: Æ-941, angiogenesis, anti-angiogenic agent, clinical trial, Neovastat, renal cell carcinoma


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