A Summary of Phase II Cederanib Clinical Trial

The summary of the phase 2 clinical trial of Cediranib on Alveolar Soft Part Sarcoma was recently published in the “Journal of Clinical Oncology” by Shivaani Kummar and others from the National Cancer Institute and the Frederick National Laboratory for Cancer Research.

The authors report that Cediranib has substantial single-agent activity, producing an objective response rate of 35% and a disease control rate of 84% at 24 weeks of treatment. On the basis of these results, they report on the opening of an “open-label, multicenter, randomized” phase II registration trial for patients with metastatic ASPS comparing Cediranib with Sunitinib, which is another VEGFR inhibitor. 

Below is the abstract from this important scientific publication: 

Purpose

Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor, for which no effective standard systemic treatment exists for patients with unresectable disease. Cediranib is a potent, oral small-molecule inhibitor of all three vascular endothelial growth factor receptors (VEGFRs). 

Patients and Methods

We conducted a phase II trial of once-daily cediranib (30 mg) given in 28-day cycles for patients with metastatic, unresectable ASPS to determine the objective response rate (ORR). We also compared gene expression profiles in pre- and post-treatment tumor biopsies and evaluated the effect of cediranib on tumor proliferation and angiogenesis using positron emission tomography and dynamic contrast-enhanced magnetic resonance imaging. 

Results

Of 46 patients enrolled, 43 were evaluable for response at the time of analysis. The ORR was 35%, with 15 of 43 patients achieving a partial response. Twenty-six patients (60%) had stable disease as the best response, with a disease control rate (partial response + stable disease) at 24 weeks of 84%. Microarray analysis with validation by quantitative real-time polymerase chain reaction on paired tumor biopsies from eight patients demonstrated downregulation of genes related to vasculogenesis. 

Conclusion

In this largest prospective trial to date of systemic therapy for metastatic ASPS, we observed that cediranib has substantial single-agent activity, producing an ORR of 35%

Click here to download the full publication.

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Yosef Landesman, Ph.D.
President & Cancer Research Director
Cure Alveolar Soft Part Sarcoma International (iCureASPS)
e-mail: landesmany@yahoo.com