NCT00264004

Brief Summary

The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_2

Geographic Reach
3 countries

6 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

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 29, 2012

Completed
Last Updated

August 29, 2012

Status Verified

July 1, 2012

Enrollment Period

1.2 years

First QC Date

December 9, 2005

Results QC Date

July 26, 2012

Last Update Submit

July 26, 2012

Conditions

Tumors

Keywords

Advanced Solid Tumoursphase IIHypertensionRECENTIN

Outcome Measures

Primary Outcomes (2)

  • Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171

    12 week treatment period

  • Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171

    Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)

    12 week treatment period

Secondary Outcomes (3)

  • Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171

    First 6 weeks of 12 week treatment period

  • Objective Response Rate

    12 week treatment period

  • Best Percentage Change in Tumour Size

    Randomisation until end of treatment period

Study Arms (2)

1

EXPERIMENTAL

30 mg AZD2171

Drug: AZD2171

2

EXPERIMENTAL

45 mg AZD2171

Drug: AZD2171

Interventions

AZD2171DRUG

30 mg \& 45 mg oral tablet

Also known as: Cediranib, RECENTIN™
12

Eligibility Criteria

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

You may qualify if:

  • Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.

You may not qualify if:

  • Prior treatment with a VEGF inhibitor
  • Poorly controlled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Freiburg im Breisgau, Germany

Location

Research Site

Hamburg, Germany

Location

Research Site

Amsterdam, Netherlands

Location

Research Site

Nijmegen, Netherlands

Location

Research Site

Utrecht, Netherlands

Location

Research Site

Surrey, United Kingdom

Location

MeSH Terms

Conditions

NeoplasmsHypertension

Interventions

cediranib

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Jane Robertson, 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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

November 1, 2005

Primary Completion

January 1, 2007

Study Completion

April 1, 2011

Last Updated

August 29, 2012

Results First Posted

August 29, 2012

Record last verified: 2012-07

Locations

DE(2)NL(3)GB(1)