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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00501605
First received: July 13, 2007
Last updated: January 20, 2011
Last verified: January 2009
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501605

Locations
Germany
Research Site
Freiburg, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: J. Drevs, PD Klinik fur.Internistische Onkologie
  More Information

No publications provided

ClinicalTrials.gov 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
AZD2171
advanced solid tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
 Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 21, 2013