Clinical trial NCT00981721: A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignancies
Keywords: Phase I
Advanced solid malignancies
Advanced solid tumour
Advanced cancer
Cediranib (RECENTIN™, AZD2171)
China
PK
pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Multiple assessments in the first 6 days
Secondary outcomes:
measure: To assess the pharmacokinetics of multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignant tumours
timeFrame: Multiple assessments up to day 29
measure: To assess the safety and tolerability of single and multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignancies.
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Hong Kong
country: China
facility: Research Site
state: Hong Kong
Study officials:
affiliation: AstraZeneca China MC
name: Jeannie Hou
role: STUDY_DIRECTOR
affiliation: Cancer Hospital, CAMS&PUMC, China
name: Sun Yan, Prof
role: PRINCIPAL_INVESTIGATOR
References: