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A Phase I, Open Label Study of the Pharmacokinetics and Safety of Cediranib (RECENTINTM, AZD2171) Following Single and Multiple Oral Doses in Patients With Advanced Solid Tumours With Various Degrees of Hepatic Dysfunction


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer, Hepatic Impairment

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Trial Information

A Phase I, Open Label Study of the Pharmacokinetics and Safety of Cediranib (RECENTINTM, AZD2171) Following Single and Multiple Oral Doses in Patients With Advanced Solid Tumours With Various Degrees of Hepatic Dysfunction


Inclusion Criteria:



- Written informed consent

- Advanced solid tumour (not prostate cancer) for which no standard therapy exists

- WHO performance status 0-2

- Bilirubin levels within the target range

Exclusion Criteria:

- Unstable brain/meningeal metastases

- Inadequate bone marrow reserve

- Biochemistry/haematology results outside of required ranges

- History of significant GI impairment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the single dose pharmacokinetics (PK) of Cediranib, in patients with cancer with various degrees of hepatic dysfunction (defined by bilirubin levels).

Outcome Time Frame:

Single dose PK assessed on Day 1 of dosing

Safety Issue:

No

Principal Investigator

CML van Herpen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

D8480C00032

NCT ID:

NCT00621725

Start Date:

January 2008

Completion Date:

June 2013

Related Keywords:

  • Advanced Cancer
  • Hepatic Impairment
  • Advanced cancer
  • metastatic
  • hepatic impairment
  • Neoplasms
  • Liver Diseases

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