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AZD1152 in Patients With Advanced Solid Malignancies-Study 1

A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2 Hour Intravenous Infusion on Two Dose Schedules in Patients With Advanced Solid Malignancies

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00497731
Enrollment
70
Registered
2007-07-09
Start date
2005-05-31
Completion date
2009-04-30
Last updated
2009-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

Advanced solid tumors

Brief 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.

Interventions

2-hour continuous intravenous infusion

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frame
Safety and TolerabilityAssessed at each visit

Secondary

MeasureTime frame
PharmacokineticsAssessed at predetermined timepoints after dose administration
Effect on biomarkersAssessed after treatment
Anti-tumor activityAssessed after treatment

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026