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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Malignancies

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

Multiple assessments in the first 6 days

Safety Issue:

No

Principal Investigator

Jeannie Hou

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca China MC

Authority:

China: Food and Drug Administration

Study ID:

D8480C00060

NCT ID:

NCT00981721

Start Date:

September 2009

Completion Date:

April 2011

Related Keywords:

  • Advanced Solid Malignancies
  • Phase I
  • Advanced solid malignancies
  • Advanced solid tumour
  • Advanced cancer
  • Cediranib (RECENTIN™, AZD2171)
  • China
  • PK
  • pharmacokinetics
  • Neoplasms

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