NCT00501605

Brief Summary

Single centre recruiting approximately 80 patients who are given a rising single, followed by multiple, ascending oral dose of AZD2171, assessing the safety and tolerability of AZD2171 in patients with solid tumors and metastatic liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2003

Typical duration for phase_1

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

February 1, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
Last Updated

January 21, 2011

Status Verified

January 1, 2009

Enrollment Period

2.2 years

First QC Date

July 13, 2007

Last Update Submit

January 20, 2011

Conditions

Advanced Solid TumorLiver Metastases

Keywords

Phase IAZD2171advanced solid tumors

Outcome Measures

Primary Outcomes (1)

  • primary objective is to evaluate the safety and tolerability of ascending single&multiple oral doses of AZD2171 by assessment of AEs,BP,HR,RR,ECG,clinical chemistry,haematology,urinalysis incl 24hr collection for protein&creatinine and physical exam.

Secondary Outcomes (1)

  • PK,assess the effects of AZD2171 on surrogate markets of activity and to make a preliminary assessment of anti-tumor activity by measurement of tumor response and time to progression

Interventions

AZD2171DRUG

Eligibility Criteria

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

You may qualify if:

  • Provision of written informed consent
  • Male/female, 18 yr or over
  • WHO status 0-2
  • Refractory advanced solid tumor

You may not qualify if:

  • Radiotherapy within 4 weeks of starting AZD2171 treatment
  • Low haemoglobin level
  • Low platelet or neutrophil counts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Freiburg im Breisgau, Germany

Location

MeSH Terms

Interventions

cediranib

Study Officials

  • Nick Botwood, BSc, MBBS, MRCP, MFPM

    AstraZeneca

    STUDY DIRECTOR

  • J. Drevs, PD

    Klinik fur.Internistische Onkologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Study Start

February 1, 2003

Primary Completion

April 1, 2005

Study Completion

February 1, 2006

Last Updated

January 21, 2011

Record last verified: 2009-01

Locations

DE(1)