Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 13, 2007
Last updated: January 20, 2011
Last verified: January 2009

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 Intervention Phase
Advanced Solid Tumor
Liver Metastases
Drug: AZD2171
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 80
Study Start Date: February 2003
Study Completion Date: February 2006
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided Identifier: NCT00501605     History of Changes
Other Study ID Numbers: D8480C00001
Study First Received: July 13, 2007
Last Updated: January 20, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Phase I
advanced solid tumors

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on November 20, 2014