AZD1152 in Patients With Advanced Solid Malignancies-Study 1

June 19, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Terminated

Conditions

Solid Tumors

Intervention / Treatment

Drug: AZD1152

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Amsterdam, Netherlands
    - Research Site
  - Utrecht, Netherlands
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability Time Frame: Assessed at each visit	Assessed at each visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics Time Frame: Assessed at predetermined timepoints after dose administration	Assessed at predetermined timepoints after dose administration
Effect on biomarkers Time Frame: Assessed after treatment	Assessed after treatment
Anti-tumor activity Time Frame: Assessed after treatment	Assessed after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: Jan Schellens, MD, NKI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

July 5, 2007

First Submitted That Met QC Criteria