A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies

A Phase I, Randomised, Multi-centre, Open-label Study to Determine the Pharmacokinetics and Tolerability of Cediranib (RECENTIN™, AZD2171) Following a Single and Multiple Oral 20mg or 30 mg Doses in Chinese Patients With Advanced Solid Malignancies

This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.

The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.

Inclusion Criteria:

• Provision of informed consent
• Histological and/or cytological confirmed advanced solid malignancies
• Refractory to conventional therapeutic modalities, or for which no appropriate therapies exist

Exclusion Criteria:

• For the first question: 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 antihypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilize blood pressure.
• Significant haemorrhage (>30 ml/bleeding episode in previous 3 months), haemoptysis (>5 ml fresh blood in previous 4 weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months
• Recent(<28 days) major thoracic and abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed.