AZD1152 in Patients With Advanced Solid Malignancies

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 or 48-hour Intravenous Infusions in Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338182
• Other study ID #: D1531C00002
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2006
• Last updated: April 21, 2017
• Start date: May 23, 2006
• Est. completion date: March 1, 2017

Study information

• Verified date: April 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• 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 48-hour infusion every 14 days and as a 2-hour infusion for 2 consecutive days every 14 days in patients with advanced solid malignancies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 1, 2017
• Est. primary completion date: June 6, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Histological or cytological confirmation of a solid, malignant tumour

• At least one measurable or non-measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Exclusion Criteria:

• Participation in an investigational drug study within the 21 days prior to therapy or those who have not recovered from the effects of an investigational study drug

• Recent major surgery within 4 weeks prior to entry into the study

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• AZD1152 part A
48-hour continuous intravenous infusion
• AZD1152 part B
2-hour intravenous infusion

Locations

Country	Name	City	State
United States	Research Site	Boston	Massachusetts
United States	Research Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG)	Safety and tolerability will be assessed through the incidence of adverse events. Adverse events will include significant findings on vital signs, clinical chemistry/haematology, coagulation parameters and electrocardiograms (ECGs).	Throughout the study. Approximately 9 months for most patients.
Secondary	Assessment of pharmacodynamic biomarker changes	Evaluation of AZD1152 activity in the tumour by assessment of pharmacodynamic biomarker changes which may include, but are not limited to biomarkers of Aurora kinase activity.	Biopsies of tumour at baseline and Cycle 1 [at pre-dose, after Screening to Day 1; and between Days 16-19 (preferrably within 24 hours of completing infusions on Day 17 (Part A) and Day 16 (Part B).]

External Links

•   Link
•   CSR-D1531C00002.pdf