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

April 14, 2010 updated by: AstraZeneca

Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Germany
    • Baden-Wurttemberg
      • Freiburg, Baden-Wurttemberg, Germany
        • Research Site
    • Ruhr
      • Essen, Ruhr, Germany
        • Research Site
      • Herne, Ruhr, Germany
        • 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AZD2171 Monotherapy
Drug: AZD2171
oral tablet multiple ascending doses 20, 30 or 45 mg
Other Names:
  • RECENTIN™
  • cediranib
Experimental: 2
AZD2171 + AZD0530
Drug: AZD2171
oral tablet multiple ascending doses 20, 30 or 45 mg
Other Names:
  • RECENTIN™
  • cediranib
Drug: AZD0530
oral tablet multiple ascending doses 125 mg or 175 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: assessed at each visit
assessed at each visit

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Jane Roberston, AstraZeneca
  • Principal Investigator: Tanja Trarbach, MD, Universitatsklinikum der GHS Essen

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, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 18, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Estimate)

April 15, 2010

Last Update Submitted That Met QC Criteria

April 14, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8480C00014
  • EuDract #2006-003505-55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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