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NCT00497679 Clinical Trial

AZD1152 in Patients With Advanced Solid Malignancies-Study 3

Solid Tumours Clinical Trial

Official title:
A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a Continuous 7-Day Intravenous Infusion in Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00497679
Other study ID # D1531C00003
Secondary ID EudraCT: 2005-00
Status Terminated
Phase Phase 1
First received July 5, 2007
Last updated May 13, 2009
Start date August 2006
Est. completion date July 2007

Study information
Verified date May 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 7-day infusion every week and every 2 weeks in patients with advanced solid malignancies.

Recruitment information / eligibility
Status Terminated
Enrollment 45
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histological or cytological confirmation of a solid, malignant tumour

Exclusion Criteria:

- Participation in an investigational drug study within 21 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AZD1152
7-day continuous intravenous infusion

Locations
Country Name City State
United Kingdom Research Site Manchester
United Kingdom Research Site Newcastle
United Kingdom Research Site Oxford

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and Tolerability Assessed at each visit
Secondary Pharmacokinetics Assessed at predetermined timepoints after dose administration
Secondary Effect on biomarkers Assessed after treatment
Secondary Anti-tumor activity Assessed at the end of treatment
See also
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Active, not recruiting NCT01894256 - Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function Phase 1
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