Safety And Tolerability Study Of AZD2171 In Combination With AZD0530 In Patients With Advanced Solid Tumours

Study Overview

Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours

The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.

N/A

Neoplasms

DRUG: AZD2171
DRUG: AZD0530

D8480C00014
EuDract #2006-003505-55

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-05-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2010-04-14
First Submitted that Met QC Criteria 2007-05-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2010-04-15
First Posted (ESTIMATED) 2007-05-21	Results First Posted N/A	Last Verified 2010-04

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1 AZD2171 Monotherapy	DRUG: AZD2171 oral tablet multiple ascending doses 20, 30 or 45 mg
EXPERIMENTAL: 2 AZD2171 + AZD0530	DRUG: AZD2171 oral tablet multiple ascending doses 20, 30 or 45 mg DRUG: AZD0530 oral tablet multiple ascending doses 125 mg or 175 mg

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

AZD2171 Monotherapy

DRUG: AZD2171

oral tablet multiple ascending doses 20, 30 or 45 mg

EXPERIMENTAL: 2

AZD2171 + AZD0530

DRUG: AZD2171

oral tablet multiple ascending doses 20, 30 or 45 mg

DRUG: AZD0530

oral tablet multiple ascending doses 125 mg or 175 mg

Primary Outcome Measures	Measure Description	Time Frame
Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam		assessed at each visit

Secondary Outcome Measures	Measure Description	Time Frame
Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530		assessed at each visit
Safety and efficacy		assessed at each visit
Genetic variation of pathways targeted by AZD2171 and AZD0530		assessed during study

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Written consent
Cancer diagnosis & stage
Patients for whom no standard therapy exists
World Health Organization (WHO) performance status 0-2
One or more measurable lesions

Prostate cancer
Untreated unstable brain or meningeal metastases
Specific laboratory ranges
Pregnant or breast-feeding women
Any evidence of severe or uncontrolled diseases
Participation in other trials within 30 days

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Jane Roberston, AstraZeneca

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record