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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00981721

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Malignancies	Drug: cediranib (RECENTIN TM, AZD2171)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 cediranib 20mg	Drug: cediranib (RECENTIN TM, AZD2171) 20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8
Experimental: 2 cediranib 30mg	Drug: cediranib (RECENTIN TM, AZD2171) 20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8

Arm

Intervention/Treatment

Experimental: 1

cediranib 20mg

Drug: cediranib (RECENTIN TM, AZD2171)

20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8

Experimental: 2

cediranib 30mg

Drug: cediranib (RECENTIN TM, AZD2171)

20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.