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TerminatedNCT00497731Updated Jun 22, 2009

AZD1152 in Patients With Advanced Solid Malignancies-Study 1

A Phase 1 interventional study of AZD1152 in Solid Tumors, sponsored by AstraZeneca. Terminated at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-22.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Why this study was terminated
Efficacy seen in the solid tumour patient population was not sufficient to continue research with AZD1152 monotherapy in solid tumors at that time.
Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.

02

Conditions studied

  • Solid Tumors

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Keywords

  • Advanced solid tumors
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 70 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms 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

  • Histological or cytological confirmation of a solid, malignant tumour
  • At least measurable or non measurable site of disease as defined by modified RECIST criteria.

Exclusion criteria

Exclusion Criteria:

  • Participation in an investigational drug study within 30 days prior to entry or who have not recovered from the effects of an investigational study drug
  • Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
  • Recent major surgery within 4 weeks prior to entry to the study
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Interventions

  • DrugAZD1152

    2-hour continuous intravenous infusion

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability

    Time frame: Assessed at each visit

Secondary outcomes

  1. Pharmacokinetics

    Time frame: Assessed at predetermined timepoints after dose administration

  2. Effect on biomarkers

    Time frame: Assessed after treatment

  3. Anti-tumor activity

    Time frame: Assessed after treatment

07

Study locations

2 sites
  • Research Site
    Amsterdam, Netherlands
  • Research Site
    Utrecht, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00497731
Lead sponsor
AstraZeneca
First posted
Jul 9, 2007
Start date
May 2005
Primary completion
Jun 2008
Completion
Apr 2009 (estimated)
Last update
Jun 22, 2009

Study contacts

Jan Schellens, MD
principal investigator · NKI

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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