NCT00748891

Brief Summary

This study is being carried out in patients with advanced solid tumours to assess which of two different types of imaging scans best measures activity of an experimental drug called Cediranib. The study compares the imaging tests: Dynamic Contrast Enhanced CT (DCE-CT) and Dynamic Contrast Enhanced MRI (DCE-MRI). It looks at which of these scans is the most accurate and best predicts a response to the treatment. Cediranib is thought to work by stopping blood flow to cancers, and both of these scans assess blood flow. Studying the response of cancers by measuring changes in their blood flow may provide useful information that will guide the way we manage cancers in the future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

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

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

Enrollment Period

1.5 years

First QC Date

September 5, 2008

Last Update Submit

June 30, 2011

Conditions

Cancer

Keywords

Cancertumouradvanced sold tumourimagingDCE-CT ScanDCE-MRI scanCediranibRecentin

Outcome Measures

Primary Outcomes (2)

  • Percentage change in DCE-MRI and DCE-CT vascular parameters. Comparison between vascular parameters of each imaging modality and between modalities.

    DCE-MRI and DCE-CT scans taken at Baseline, Day 7 and Day 28. Comparison between modalities from scans taken on Days -8 and Day-1.

  • Baseline measurements for DCE-MRI-iAUC60(mMol/sec),Ktrans(min-1),ve,vp,kep(min-1,Enhancing Fraction% DCE-CT-Permeability Surface Product(ml/min/100g),Perfusion(ml/min/100g),Mean Transit Time(sec),Blood Volume (ml/100g),Positive Enhancement Integral(Hus).

    DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28

Secondary Outcomes (2)

  • Objective tumour response (RECIST )Progression free survival

    RECIST scans within 4 weeks prior to first dose then 8 weekly up to 24 weeks, then 12 weekly thereafter

  • Baseline and on treatment time-point measurements for iAUC60 (mMol/sec) and Positive Enhancement Integral (Hus)

    DCE-MRI and DCE-CT scans taken at Day -8, Day -1, Day 7 and Day 28

Study Arms (1)

1

EXPERIMENTAL

Open label 30mg Cediranib administered once daily during scanning phase and if tolerated by patient, until disease progression

Drug: Recentin (Cediranib)

Interventions

Recentin (Cediranib)DRUG

30mg once daily, 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:

  • Histologically confirmed metastatic tumour which is refractory to standard therapies
  • At least one lesion size ≥3cm on in longest diameter suitable for repeat assessment by DCE-CT and DCE-MRI
  • Patients must be able to undergo DCE-CT and DCE-MRI scanning procedures
  • Life expectancy of at least 12 weeks

You may not qualify if:

  • Patients with hormone refractory prostate cancer (HRPC)
  • Patients with a history of poorly controlled high blood pressure
  • Ineligibility for MRI scanning or DCE-CT or DCE-MRI scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

Related Publications (1)

  • Messiou C, Orton M, Ang JE, Collins DJ, Morgan VA, Mears D, Castellano I, Papadatos-Pastos D, Brunetto A, Tunariu N, Mann H, Tessier J, Young H, Ghiorghiu D, Marley S, Kaye SB, deBono JS, Leach MO, deSouza NM. Advanced solid tumors treated with cediranib: comparison of dynamic contrast-enhanced MR imaging and CT as markers of vascular activity. Radiology. 2012 Nov;265(2):426-36. doi: 10.1148/radiol.12112565. Epub 2012 Aug 13.

    PMID: 22891356DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

cediranib

Study Officials

  • Jane Robertson, MD

    AstraZeneca, Alderley Park

    STUDY DIRECTOR

  • Johann De Bono, MD

    Institute of Cancer Research, Royal Marsden Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 9, 2008

Study Start

August 1, 2008

Primary Completion

February 1, 2010

Study Completion

November 1, 2010

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations

GB(1)