NCT00306891

Brief Summary

The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

March 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

November 1, 2012

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

1.6 years

First QC Date

March 23, 2006

Results QC Date

April 3, 2012

Last Update Submit

October 3, 2012

Conditions

Cancer

Keywords

Advanced solid tumoursAdvanced cancertumortumourRECENTIN

Outcome Measures

Primary Outcomes (2)

  • Part A: Area Under Plasma Concentration-time Curve (AUC)

    Area under plasma concentration-time curve from zero to infinity

    Measurements were collected up to 168 hours (following single dosing).

  • Part A: Maximum Plasma (Peak) Concentration (Cmax)

    Maximum plasma drug concentration

    Measurements were collected up to 168 hours (following single dosing).

Secondary Outcomes (6)

  • Part A: AUC (0-t)

    Measurements were collected up to 168 hours (following single dosing).

  • Part A: Time to Peak or Maximum Concentration (Tmax)

    Measurements were collected up to 168 hours (following single dosing).

  • Part A: Terminal Phase Half-life (t1/2λz)

    Measurements were collected up to 168 hours (following single dosing).

  • Part A: Apparent Total Body Clearance (CL/F)

    Measurements were collected up to 168 hours (following single dosing).

  • Part B: Best Overall Response Rate (ORR)

    Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.

  • +1 more secondary outcomes

Study Arms (4)

Cediranib 45 mg Fed

EXPERIMENTAL

Part A: Cediranib 45 mg Fed State

Drug: Cediranib

Cediranib 45 mg Fasted

EXPERIMENTAL

Part A: Cediranib 45 mg Fasted State

Drug: Cediranib

Cediranib 45 mg Fixed Dose

EXPERIMENTAL

Part B: Cediranib 45 mg Fixed Dose

Drug: Cediranib

Cediranib 30 - 90 mg Dose Escalation

EXPERIMENTAL

Part B: Cediranib 30 - 90 mg Dose Escalation

Drug: Cediranib 30 - 90 mg

Interventions

CediranibDRUG

45 mg oral dose

Also known as: RECENTIN™
Cediranib 45 mg FastedCediranib 45 mg FedCediranib 45 mg Fixed Dose
Cediranib 30 - 90 mgDRUG

oral tablet dose escalation

Also known as: RECENTIN™
Cediranib 30 - 90 mg Dose Escalation

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of advanced solid tumour.
  • Ability to eat a high fat breakfast

You may not qualify if:

  • Poorly controlled high blood pressure.
  • History of significant gastrointestinal problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Glasgow, United Kingdom

Location

Research Site

Headington, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

cediranib

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • AstraZeneca AZD2171 Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 27, 2006

Study Start

June 1, 2006

Primary Completion

January 1, 2008

Study Completion

September 1, 2008

Last Updated

November 1, 2012

Results First Posted

November 1, 2012

Record last verified: 2012-10

Locations

GB(4)