(duplicate) Pazopanib versus placebo in Soft Tissue Sarcoma

• Research type

  Research Study

• Full title

  Randomised double blind phase III study on Pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy

• IRAS ID

  13490

• Contact name

  Michael Leahy

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2008-001307-33

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The primary objective of this study is to compare progression free survival of patients on pazopanib compared to placebo who have metastatic soft tissue sarcoma and have completed all available standard chemotherapy (which must have included chemotherapy with the drug doxorubicin).The usual treatment for these patients is best supportive care. This means that symptoms would be relieved and the patient kept well for as long as possible. ; Pazopanib is a tablet treatment which acts to prevent or delay new blood vessel formation which is necessary for growing tumours. This treatment has been tested in a previous uncontrolled study for patients with sarcomas and appeared to increase the time until the tumours started to grow after chemotherapy (progression free survival)Progression free survival will be measured by CT scans, performed every four weeks for the first three months of treatment and thereafter every eight weeks, and is defined as the amount of time between the date of randomisation and the date of disease progression or death.Safety assessments will be performed on a regular basis including haematology, biochemistry, cardiac assessments and adverse event assessment.Patient visits will be on day 1, day 8 then every four weeks for the first 12 weeks then every eight weeks until study treatment is discontinued. The patient will then be followed every three months for survival where a clinical examination will be performed.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  08/H1010/118

• Date of REC Opinion

  18 Dec 2008

• REC opinion

  Favourable Opinion