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

Phase 1

Completed

• Conditions: Advanced Solid Malignancies
• Interventions: Drug: cediranib (RECENTIN TM, AZD2171)

• Registration Number: NCT00981721
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2010-05
• Study Completion: 2011-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-17
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cediranib (RECENTIN TM, AZD2171)	cediranib 20mg
2	cediranib (RECENTIN TM, AZD2171)	cediranib 30mg

Primary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics of single dose of cediranib 20mg or 30 mg by assessment of area under the curve over the time (AUC) and maximum concentration in Chinese patients with advanced solid malignant tumours	Multiple assessments in the first 6 days

Secondary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics of multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignant tumours	Multiple assessments up to day 29
To assess the safety and tolerability of single and multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignancies.	Safety assessments to be taken until Day 29 (while patient remains on study treatment), then every 4 weeks until treatment discontinuation and then 30 day follow up

Trial Locations

Locations (1)

Research Site; 🇨🇳 Hong Kong, Hong Kong, China