AZD1152 in Patients With Advanced Solid Malignancies

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338182

Enrollment

Registered

2006-06-20

Start date

2006-05-23

Completion date

2017-03-01

Last updated

2017-04-24

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

Conditions

Tumors

Keywords

Solid tumor

Brief 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.

Interventions

DRUGAZD1152 part A

48-hour continuous intravenous infusion

DRUGAZD1152 part B

2-hour intravenous infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 130 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG)	Throughout the study. Approximately 9 months for most patients.	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).

Secondary

Measure	Time frame	Description
Assessment of pharmacodynamic biomarker changes	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).]	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.

Countries

United States

Outcome results

None listed

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