Advanced Solid Malignancies
Conditions
Keywords
Phase I, Advanced solid malignancies, Advanced solid tumour, Advanced cancer, Cediranib (RECENTIN™, AZD2171), China, PK, pharmacokinetics
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.
Interventions
20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed