None listed
Conditions
Brief summary
This study is investigating whether the drug cediranib might be effective as a treatment for alveolar soft part sarcoma. It will test cediranib against placebo and measure the effects after 24 weeks. Who is it for? You may be eligible for this study if you are aged 16 years and over, have a histologically confirmed diagnosis of alveolar soft part sarcoma and give your consent to take part. The full inclusion criteria details can be found in the relevant section of this form. Trial details: In this study, you will receive either the drug cediranib or placebo in the form of one tablet once a day, taken orally over a total period of 24 weeks. If you are allocated to placebo, you will switch to cediranib after 24 weeks (or if your disease progresses before this time). If you are allocated to cediranib, you will continue on this treatment until such time as your disease progresses. You will be required to attend regular clinic visits for routine tests and assessments.
Interventions
Cediranib; 30mg tablet once daily, orally; until disease progression
Sponsors
The Institute of Cancer Research / Royal Marsden Hospital NHS Foundation Trust (UK)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed diagnosis of Alveolar Soft Part Sarcoma (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 within 6 months prior to randomisation 7. Measurable metastatic disease using RECISTv1.1, i.e. at least one lesion 10mm in diameter (15mm in short axis for nodal lesions) assessable by spiral CT (or MRI for brain metastases) 8. Patients with brain metastases are permitted provided disease is controlled with a stable dose of coricosteroid and/or non-enzyme inducing anticonvulsent 9. The capacity to understand the patient information sheet and ability to provide written informed consent 10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures 11. Able to swallow and retain oral medication
Exclusion criteria
1. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count <=1.5 x 10^9/L or platelet count <=100 x 10^9/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/sqRR) or history of familial long QT syndrome 10. Significant recent haemorrhage (>30mL bleeding/ episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks) 11. Major thoracic or abdominal surgery in the 14 days prior to entry into the study, or a surgical incision that is not fully healed 12. Pregnant or breast-feeding women; women of childbearing potential with a positive pregnancy test prior to receiving study medication; women the intention of pregnancy during study treatment; women of child bearing potential unwilling to have a urine or serum pregnancy test prior to study entry (even if surgically sterilised) 13. Men and women of childbearing potential unwilling to use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilisation) for the duration of the study and should continue such precautions for 2 weeks after receiving the last study treatment 14. History of anticancer (including investigational, non-registered) treatment in the four weeks prior to first dose of cediranib, with the exception of palliative radiotherapy for symptom control 15. Known hypersensitivity to cediranib or any of its excipients 16. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for 2 years and there is a tissue diagnosis of the primary cancer of interest from a target lesion 17. Other concomitant anti-cancer therapy (including LHRH agonists) except steroids 18. Recent history of thrombosis 19. Patients with brain metastases if they are symptomatic requiring increasing steroids in the previous six weeks to study entry or those with evidence of recent and/or active bleeding, or those causing uncontrolled seizures
Outcome results
None listed