Phase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501605
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : January 21, 2011
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Brief Summary:
Single centre recruiting approximately 80 patients who are given a rising single, followed by multiple, ascending oral dose of AZD2171, assessing the safety and tolerability of AZD2171 in patients with solid tumors and metastatic liver disease.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Liver Metastases Drug: AZD2171 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Single Centre 2-part Open Study to Assess the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients With Advanced Solid Malignant Tumors and Liver Metastases
Study Start Date : February 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : February 2006

Primary Outcome Measures :
  1. primary objective is to evaluate the safety and tolerability of ascending single&multiple oral doses of AZD2171 by assessment of AEs,BP,HR,RR,ECG,clinical chemistry,haematology,urinalysis incl 24hr collection for protein&creatinine and physical exam.

Secondary Outcome Measures :
  1. PK,assess the effects of AZD2171 on surrogate markets of activity and to make a preliminary assessment of anti-tumor activity by measurement of tumor response and time to progression

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Provision of written informed consent
  • Male/female, 18 yr or over
  • WHO status 0-2
  • Refractory advanced solid tumor

Exclusion Criteria:

  • Radiotherapy within 4 weeks of starting AZD2171 treatment
  • Low haemoglobin level
  • Low platelet or neutrophil counts

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501605

Research Site
Freiburg, Germany
Sponsors and Collaborators
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: J. Drevs, PD Klinik fur.Internistische Onkologie Identifier: NCT00501605     History of Changes
Other Study ID Numbers: D8480C00001
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: January 2009

Keywords provided by AstraZeneca:
Phase I
advanced solid tumors

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action