Phase 2 study of ABT-510 in patients with previously untreated advanced renal cell carcinoma

Scot Ebbinghaus*, Maha Hussain, Nizar Tannir, Michael Gordon, Apurva A. Desai, Raymond A. Knight, Rod A. Humerickhouse, Jiang Qian, Gary B. Gordon, Robert Figlin

*Corresponding author for this work

Research output: Contribution to journalArticle

61 Scopus citations

Abstract

Purpose: Angiogenesis is a characteristic of renal cell carcinoma. ABT-510 is an angiogenesis inhibitor that mimics the antiangiogenic properties of thrombospondin-1. This study was designed to assess the safety and efficacy of ABT-510 in patients with advanced renal cell carcinoma. Experimental Design: Patients with previously untreated metastatic or unresectable renal cell carcinoma were randomized to treatment with one of two doses of ABT-510, self-administered s.c. twice daily in 28-day treatment periods without intervening rest periods. End points were progression-free survival (PFS), objective response rate, overall survival, and toxicity. Results: The objective response rate was 4% in the 10 mg twice daily group, and there were two unconfirmed PRs in the 100 mg twice daily group. Respective median PFS was 4.2 and 3.3 months, with a 6-month PFS of 39% and 32%. Median overall survival was 27.8 months (10 mg twice daily) and 26.1 months (100 mg twice daily). The most frequent adverse events were injection site reactions (84%), fatigue (50%), headache (20%), and nausea (19%). The incidence of treatment-related, grade 3/4 adverse events was low and included three bleeding episodes (gastrointestinal hemorrhage, intracranial hemorrhage, and hemoptysis) and one thrombotic event (deep vein thrombosis). No deaths were attributed to ABT-510. Conclusions: There was little evidence of clinical activity for ABT-510, and further evaluation as a single agent for treating advanced renal cell carcinoma is not warranted. The evidence of a favorable safety profile may justify further evaluation in combination therapy.

Original languageEnglish (US)
Pages (from-to)6689-6695
Number of pages7
JournalClinical Cancer Research
Volume13
Issue number22
DOIs
StatePublished - Nov 15 2007

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Ebbinghaus, S., Hussain, M., Tannir, N., Gordon, M., Desai, A. A., Knight, R. A., Humerickhouse, R. A., Qian, J., Gordon, G. B., & Figlin, R. (2007). Phase 2 study of ABT-510 in patients with previously untreated advanced renal cell carcinoma. Clinical Cancer Research, 13(22), 6689-6695. https://doi.org/10.1158/1078-0432.CCR-07-1477