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CompletedNCT00475956Updated Apr 15, 2010

Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours

A Phase 1 interventional study of AZD2171 and AZD0530 in Neoplasms, sponsored by AstraZeneca. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-15.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.

02

Conditions studied

  • Neoplasms

Keywords

  • Cancer
  • Tumour
  • Advanced Solid Tumour
  • Lung Cancer
  • Breast Cancer
  • Cholangiocarcinoma
  • Colon Cancer
  • Gastric Cancer
  • Choriocarcinoma
  • Liver Cancer
  • Myeloma
  • Ovarian Cancer
  • Pancreatic Cancer
  • Peritoneal Cancer
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written consent
  • Cancer diagnosis \& stage
  • Patients for whom no standard therapy exists
  • World Health Organization (WHO) performance status 0-2
  • One or more measurable lesions

Exclusion criteria

Exclusion Criteria:

  • Prostate cancer
  • Untreated unstable brain or meningeal metastases
  • Specific laboratory ranges
  • Pregnant or breast-feeding women
  • Any evidence of severe or uncontrolled diseases
  • Participation in other trials within 30 days
05

Study design

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

Study arms

  • Experimental
    1

    AZD2171 Monotherapy

    Drug: AZD2171

  • Experimental
    2

    AZD2171 + AZD0530

    Drug: AZD2171 · Drug: AZD0530

Interventions

  • oral tablet multiple ascending doses 20, 30 or 45 mg

    Also known as: cediranib, RECENTIN™

  • oral tablet multiple ascending doses 125 mg or 175 mg

06

What researchers measure

Primary outcomes

  1. Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam

    Time frame: assessed at each visit

Secondary outcomes

  1. Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530

    Time frame: assessed at each visit

  2. Safety and efficacy

    Time frame: assessed at each visit

  3. Genetic variation of pathways targeted by AZD2171 and AZD0530

    Time frame: assessed during study

07

Study locations

3 sites
  • Research Site
    Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Research Site
    Essen, Ruhr, Germany
  • Research Site
    Herne, Ruhr, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2007, a primary completion of Oct 2008 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2007
First posted
May 21, 2007
Start
May 2007
Primary completionActual
Oct 2008
CompletionActual
Oct 2009
Last update
Apr 15, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00475956
Lead sponsor
AstraZeneca
First posted
May 21, 2007
Start date
May 2007
Primary completion
Oct 2008
Completion
Oct 2009
Last update
Apr 15, 2010

Study contacts

Jane Roberston
study director · AstraZeneca
Tanja Trarbach, MD
principal investigator · Universitatsklinikum der GHS Essen
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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