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AZD5438 in Patients With Advanced Solid Malignancies

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: August 4, 2004
Last updated: January 25, 2011
Last verified: January 2011
Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the development of AZD5438 as a potential anti-cancer agent would be discontinued.

Condition Intervention Phase
Neoplasms Drug: AZD5438 Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study to Assess the Safety and Tolerability of AZD5438 in Patients With Advanced Solid Malignancies

Further study details as provided by AstraZeneca:

Study Start Date: July 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Advanced solid malignancy
  • Cancer refractory to standard treatments or for which no standard therapy exits

Exclusion Criteria:

  • Radiotherapy within 3 weeks of the start of treatment
  • Investigational product within the last 3 weeks
  • Systemic cytotoxic anti-cancer therapy within the last 3 weeks
  • Any significant clinical disorder that makes it undesirable for the patient to participate
  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: NCT00088790

United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
New York City, New York, United States
Sponsors and Collaborators
  More Information Identifier: NCT00088790     History of Changes
Other Study ID Numbers: D0110C00005
Study First Received: August 4, 2004
Last Updated: January 25, 2011

Keywords provided by AstraZeneca:
advanced, solid, malignancies processed this record on August 18, 2017