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AZD5438 in Patients With Advanced Solid Malignancies

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00088790
First received: August 4, 2004
Last updated: January 25, 2011
Last verified: January 2011
History of Changes
  Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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)
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088790

Locations
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
AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00088790     History of Changes
Other Study ID Numbers: D0110C00005
Study First Received: August 4, 2004
Last Updated: January 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
advanced, solid, malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013