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Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours

Primary Purpose

Advanced Cancer, Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AZD2171

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring Advanced cancer, metastatic, hepatic impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Single and multiple dose PK assessed on Day 1 of the single dosing period and Day 21 of the multiple dosing period, respectively (minimum 7 day washout following single dosing)

Full Information

NCT ID

NCT00621725

First Posted

February 13, 2008

Last Updated

July 14, 2014

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00621725

Brief Title

Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Cancer, Hepatic Impairment

Keywords

Advanced cancer, metastatic, hepatic impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AZD2171

Other Intervention Name(s)

Cediranib

Intervention Description

Oral dose

Primary Outcome Measure Information:

Title

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

Time Frame

Single dose PK assessed on Day 1 of dosing

Secondary Outcome Measure Information:

Title

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

Description

Single and multiple dose PK assessed on Day 1 of the single dosing period and Day 21 of the multiple dosing period, respectively (minimum 7 day washout following single dosing)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

CML van Herpen, MD

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

København Ø

Country

Denmark

Facility Name

Research Site

City

Nijmegen

Country

Netherlands

Facility Name

Research Site

City

Rotterdam

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

23197081

Citation

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.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=629&filename=CSR-D8480C00032.pdf

Description

CSR-D8480C00032.pdf

Learn more about this trial

Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours

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