Axi-STS:  A clinicopathological phase II study of axitinib in patients with advanced angiosarcoma and other soft tissue sarcomas

Trial Overview and Summary

 Chief Investigator: Prof. Penella Woll
 Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
 Disease Site: Cancer Research UK (C5410/A10910)/Pfizer
 Trial Type: Sarcoma
UKCRN Study ID: Clinical Trial of an Investigational Medicinal Product
 Status: Follow-up
 UKCRN Study ID: 7030
 ISRCTN Reference Number: 60791336
 Open to New Sites? No
 Recruitment Start Date: 31-Aug-2010
 Anticipated Recruitment End Date: 29-Jan-2016
 CRCTU Trial Management Team: Late Phase Trial Management Team A
 Trial Email Address:

Trial Summary

  • View Trial Summary Document [.pdf]

A plain English summary of this trial can be found at on the Cancer Help website (see Other Websites below for the link).

Soft tissue sarcomas are a heterogeneous group of rare malignancies that account for 0.72% of new malignancies and 0.65% of malignant deaths. Advanced sarcomas carry a poor prognosis. Angiogenesis is a hallmark of tumour growth, and there is increasing evidence that antiangiogenic drugs, including axitinib, can lead to tumour regression and improve patient survival in a variety of tumours.

This study will evaluate the therapeutic activity, safety and tolerability of axitinib in patients with advanced soft tissue sarcoma, with tumours incurable by surgery or radiotherapy and unsuitable or unresponsive to standard chemotherapy. Patients with angiosarcoma, synovial sarcoma, leiomyosarcoma and other sarcomas will be separately evaluated.

Patients will take axitinib 5mg tablets by mouth twice daily. This will be continued for 2 years or until disease progression, or development of limiting toxicity. In the event of severe toxicity, axitinib will be stopped until the toxicity has improved.

Patients will be monitored once weekly for the first month, then at 4 week intervals. Disease evaluation will be carried out 12 weeks after study entry, then every 12 weeks until disease progression. After disease progression, patients will be followed up every 3 months for survival. Patients will be followed up until death or a minimum follow-up period of 1 year.

Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Trial Protocol

  • View Trial Protocol Document [.pdf]

Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.

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