NCT00423332

Brief Summary

Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2

Geographic Reach
2 countries

8 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, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

September 6, 2012

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 2, 2017

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

January 16, 2007

Results QC Date

April 3, 2012

Last Update Submit

December 8, 2016

Conditions

Renal Cell Carcinoma

Keywords

cancertumouradvanced cancerMetastatic renal cell carcinomakidney cancerRECENTIN

Outcome Measures

Primary Outcomes (1)

  • Percentage Change From Baseline in Tumour Size at 12 Weeks

    Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)\*100

    Baseline to Week 12

Secondary Outcomes (5)

  • Best Percentage Change From Baseline in Tumour Size During the Study

    Treatment period up to Week 12 visit date for last patient in (LPI)

  • Duration of Response

    Treatment period up to 2nd data cut-off of 8th March 2009

  • Progression Free Survival

    Treatment period up to 2nd data cut-off of 8th March 2009.

  • Objective Tumour Response at 12 Weeks

    Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.

  • Best Objective Tumour Response

    Baseline, Week 12 and every 8 weeks thereafter or until progression.

Study Arms (2)

1

PLACEBO COMPARATOR

Cediranib placebo

Drug: Cediranib Placebo

2

EXPERIMENTAL

Cediranib

Drug: Cediranib

Interventions

CediranibDRUG

45 mg oral tablet

Also known as: AZD2171, RECENTIN™
2
Cediranib PlaceboDRUG

oral tablet

1

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmation of metastatic or recurrent renal cell carcinoma

You may not qualify if:

  • Certain types of previous anti-cancer therapy for Renal Cell Carcinoma
  • Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes
  • Patients with a history of poorly controlled high blood pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Groningen, Netherlands

Location

Research Site

Leiden, Netherlands

Location

Research Site

Nijmegen, Netherlands

Location

Research Site

Birmingham, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

Research Site

Northwood, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

Related Publications (1)

  • Mulders P, Hawkins R, Nathan P, de Jong I, Osanto S, Porfiri E, Protheroe A, van Herpen CM, Mookerjee B, Pike L, Jurgensmeier JM, Gore ME. Cediranib monotherapy in patients with advanced renal cell carcinoma: results of a randomised phase II study. Eur J Cancer. 2012 Mar;48(4):527-37. doi: 10.1016/j.ejca.2011.12.022. Epub 2012 Jan 28.

    PMID: 22285180DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasmsKidney Neoplasms

Interventions

cediranib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Jane Robertson

    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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2007

First Posted

January 18, 2007

Study Start

January 1, 2007

Primary Completion

March 1, 2008

Study Completion

October 1, 2016

Last Updated

February 2, 2017

Results First Posted

September 6, 2012

Record last verified: 2016-11

Locations

NL(3)GB(5)