AZD1152 in Patients With Advanced Solid Malignancies-Study 1

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00497731
• Other study ID #: D1531C00001
• Status: Terminated
• Phase: Phase 1
• First received: July 5, 2007
• Last updated: June 19, 2009
• Start date: May 2005
• Est. completion date: April 2009

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• 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 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: April 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• AZD1152
2-hour continuous intravenous infusion

Locations

Country	Name	City	State
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

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 after treatment