Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 20029
© 2008 American Society of Clinical Oncology

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Abstract

A multicentre, dose finding, phase II study of CP-4055 in combination with sorafenib in patients with metastatic malignant melanoma

The Norwegian Radium Hospital, Oslo, Norway; Lund University Hospital, Lund, Sweden; Uppsala University Hospital, Uppsala, Sweden; Cancer Research Center, San Antonio, TX; University of Pittsburgh Cancer Institute, Pittsburgh, MD; Sahlgrenska University Hospital, Gothenborg, Sweden; Clavis Pharma ASA, Oslo, Norway

20029

Background: CP-4055 (5’-elaidic acid ester of cytarabine) is a novel chemical entity developed as an antineoplastic agent with observed preclinical cytotoxicity in solid tumors. Promising early phase clinical results with CP-4055 in malignant melanoma (1 PR and several long-lasting SD) have led to the present study. The aim of this study is to evaluate the antitumour effect of CP-4055 given in combination with the oral multi-kinase inhibitor sorafenib in malignant melanoma patients (pts). Methods: CP-4055 is administered at days (d) 1–5 every 4 weeks (q4w) in a 30 min infusion. Starting dose of CP-4055 was 150 mg/m²/d (3 pts) and is continuing at 200 mg/m²/d (15 pts). Sorafenib is given orally every day at 400 mg b.i.d. (800 mg/d). Activity is assessed at the end of each 2nd cycle (cy). If more than 15% response is observed among first 18 pts (step 1), 22 additional pts will be recruited (step 2). Standard hematological, biological and clinical dose limiting toxicity definitions are used. Results: 8 pts enrolled. Among 3 first pts treated with 150 mg/m²/d, 1 is ongoing at cy 5 with SD and 2 withdrew after cy 2 due to PD. The other 5 pts are ongoing in cy 2 with CP-4055 at 200 mg/m²/d. Toxicity (essentially skin rash) did not prevent the escalation of CP-4055 from 150 to 200 mg/m²/d. No significant unexpected AEs have occurred. Conclusions: Infusion of CP-4055 (200 mg/m²/d) in combination with sorafenib 400 b.i.d. is well tolerated by patients with malignant melanoma in a d1–5 q4w schedule. Recruitment is ongoing and updated results will be presented.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Clavis Pharma ASA Clavis Pharma ASA