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CompletedNCT00501605Updated Jan 21, 2011

Phase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases

A Phase 1 interventional study of AZD2171 in Advanced Solid Tumor and Liver Metastases, sponsored by AstraZeneca. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-21.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumor
  • Liver Metastases

Keywords

  • Phase I
  • AZD2171
  • advanced solid tumors
03

In context

Neoplasm Metastasis

3,514 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.

This study's planned enrollment of 80 is above the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Radiotherapy within 4 weeks of starting AZD2171 treatment
  • Low haemoglobin level
  • Low platelet or neutrophil counts
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Interventions

  • DrugAZD2171
06

What researchers measure

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

07

Study locations

1 site
  • Research Site
    Freiburg, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00501605
Lead sponsor
AstraZeneca
First posted
Jul 16, 2007
Start date
Feb 2003
Primary completion
Apr 2005
Completion
Feb 2006
Last update
Jan 21, 2011

Study contacts

Nick Botwood, BSc, MBBS, MRCP, MFPM
study director · AstraZeneca
J. Drevs, PD
principal investigator · Klinik fur.Internistische Onkologie

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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