A randomised phase II multi-centre double-blind placebo-controlled clinical trial of Cediranib in the treatment of patients with Alveolar Soft Part Sarcoma

The Institute of Cancer Research/Royal Marsden Hospital NHS Foundation Trust (UK)0 sites48 target enrollmentFebruary 7, 2011

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Alveolar soft part sarcoma
Sponsor: The Institute of Cancer Research/Royal Marsden Hospital NHS Foundation Trust (UK)
Enrollment: 48
Status: Active, not recruiting
Last Updated: 6 years ago

Registry

who.int

Start Date

February 7, 2011

End Date

January 15, 2020

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

The Institute of Cancer Research/Royal Marsden Hospital NHS Foundation Trust (UK)

•Current inclusion criteria as of 11/11/2014:
•1\. Histologically confirmed diagnosis of ASPS (central confirmation not required at study entry)
•2\. Age 16 years and older
•3\. Availability of archived tissue blocks to enable confirmation of t(X;17\) translocation
•4\. ECOG Performance Status of 0\-1
•5\. Life expectancy of \>12 weeks
•6\. Progressive disease as defined by RECIST v1\.1 within 6 months prior to randomisation
•7\. Measurable metastatic disease using RECIST v1\.1, i.e. at least one lesion 10 mm in diameter (15 mm in short axis for nodal lesions) assessable by CT (or MRI for brain metastases).
•8\. Patients with brain metastases are permitted provided disease is controlled with a stable dose of corticosteroid and/or non\-enzyme inducing anticonvulsant
•9\. The capacity to understand the patient information sheet and ability to provide written informed consent

•Current exclusion criteria as of 11/11/2014:
•1\. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count \=1\.5 x 109/L or platelet count \=100 x 109/L
•2\. Serum bilirubin \= 1\.5 x ULN (unless Gilbert?s syndrome)
•3\. ALT or AST \= 2\.5 x ULN. If liver metastases are present, ALT or AST \> 5 x ULN
•4\. Serum creatinine \> 1\.5 x ULN or a creatinine clearance (calculated or measured) of \= 50mL/min
•5\. Greater than \+1 proteinuria unless urinary protein \< 1\.5g in a 24 hr period or protein/creatinine ratio \< 1\.5\.
•6\. History of significant gastrointestinal impairment, as judged by the Investigator, that would significantly affect the absorption of cediranib.
•7\. Patients with a history of poorly controlled hypertension with resting blood pressure \>150/100 mmHg in the presence or absence of a stable regimen of anti\-hypertensive therapy.
•8\. Any evidence of severe or uncontrolled co\-morbidities e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, or active and uncontrolled infection.
•9\. Evidence of prolonged QTc \>480 msec (using Bazetts correction, for which the formula is: QTc \= QT/vRR) or history of familial long QT syndrome.