NCT00621725

Brief Summary

To determine how patients with advanced cancer and various degrees of hepatic impairment will metabolise Cediranib.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

2.5 years

First QC Date

February 13, 2008

Last Update Submit

July 14, 2014

Conditions

Advanced CancerHepatic Impairment

Keywords

Advanced cancermetastatichepatic impairment

Outcome Measures

Primary Outcomes (1)

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

    Single dose PK assessed on Day 1 of dosing

Secondary Outcomes (1)

  • Safety/tolerability of Cediranib (single and multiple dose PK)

    assessed from randomisation to data cut-off (15th July 2010)

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD2171

Interventions

AZD2171DRUG

Oral dose

Also known as: Cediranib
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unstable brain/meningeal metastases
  • Inadequate bone marrow reserve
  • Biochemistry/haematology results outside of required ranges
  • History of significant GI impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

København Ø, Denmark

Location

Research Site

Nijmegen, Netherlands

Location

Research Site

Rotterdam, Netherlands

Location

Related Publications (1)

  • van Herpen CM, Lassen U, Desar IM, Brown KH, Marotti M, de Jonge MJ. Pharmacokinetics and tolerability of cediranib, a potent VEGF signalling inhibitor, in cancer patients with hepatic impairment. Anticancer Drugs. 2013 Feb;24(2):204-11. doi: 10.1097/CAD.0b013e32835bd1d2.

    PMID: 23197081DERIVED

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

cediranib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • CML van Herpen, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 22, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2010

Study Completion

January 1, 2014

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

DK(1)NL(2)